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University Hospital Southampton NHS Foundation Trust Constitution

Description: Read our constitution here.
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/University-Hospital-Southampton-NHS-Foundation-Trust-Constitution.pdf

Papers Council of Governors 20 July 2022

Description: Agenda attachments 1 CoG Agenda - 20.07.2022.docx Date Time Location Chair Agenda Council of Governors 20/07/2022 14
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2022-Trust-documents/Papers-Council-of-Governors-20-July-2022.pdf

Celebrating ten years of the Hampshire Bowel Cancer Screening Programme

Description: Looking back on a decade of this lifesaving programme
Url: /AboutTheTrust/Newsandpublications/Latestnews/2018/April-2018/Celebrating-ten-years-of-the-Hampshire-Bowel-Cancer-Screening-Programme.aspx

Papers Trust Board - 15 July 2025

Description: Agenda Trust Board – Open Session Date 15/07/2025 Time 9:00 - 13:00 Location Conference Room, Heartbeat Education Centre Chair
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2025-Trust-documents/Papers-Trust-Board-15-July-2025.pdf

Standing Financial Instructions

Description: These Standing Financial Instructions (SFIs) are issued for the regulation of the conduct of Trust members and officers in relation to all financial matters with which they are concerned.
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Finance/StandingFinancialInstructions.pdf

Annual report 20-21

Description: 2020/21 Incorporating the quality report University Hospital Southampton NHS Foundation Trust Annual Report and Accounts 2020/21 Presented to Parliament pursuant to Schedule 7, paragraph 25(4)(a) of the National Health Service Act 2006 © 2021 University Hospital Southampton NHS Foundation Trust Table of contents Welcome from our chair and chief executive 6 Overview and performance 8 Performance report 9 Overview 10 Accountability report 29 Directors’ report 30 Remuneration report 53 Staff report 65 NHS Foundation Trust Code of Governance 81 NHS Oversight Framework 81 Annual governance statement 84 Quality report 95 Statement on quality from the chief executive 96 Priorities for improvement and statements of assurance from the board 99 Other information 153 Annual accounts 180 Statement from the chief financial officer 181 Auditor’s report 182 Foreword to the accounts 188 Statement of Comprehensive Income 189 Statement of Financial Position 190 Statement of Changes in Taxpayers’ Equity 191 Statement of Cash Flows 192 Notes to the accounts 193 5 Welcome from our chair and chief executive 2020/21 was undoubtedly the most challenging year in the history of the NHS, and we have felt the impact of the COVID-19 pandemic here at University Hospital Southampton NHS Foundation Trust (UHS) in full. Responding to this has meant there isn’t a single part of our organisation that hasn’t changed in some way over the last year and we have all had to adapt to a rapidly changing environment. Our staff have been unwavering in their dedication, hard work and commitment to keeping our hospitals running, our patients cared for, and their colleagues supported. Every single member of the UHS family has played their part. The loss of life from COVID-19 has been devastating, and at UHS we stand shoulder-to-shoulder with everyone affected by this tragedy, including the families of staff members whom we lost. We must recognise the incredible work of Southampton Hospital Charity, which has funded boost boxes, wellness rooms, a helpline and so much more to support staff at a time when their wellbeing is more important than ever. As the nationwide vaccination programme continues to offer hope of life more like pre-pandemic times, we are proud to have been at the forefront of these efforts - from being part of early research for the Oxford-AstraZeneca vaccine, to the opening of one of the largest vaccination hubs in the region on our site in December 2020. We will continue to play a key role in vaccination development by leading the world’s first clinical trial into the effectiveness of COVID-19 booster vaccines, as well as taking part in a study involving pregnant people. Our response to COVID-19 has prompted innovation and new ways of working across the Trust, to the benefit of patient experience. At the start of the pandemic we faced real challenges of capacity and increases in waiting times, which led to us working with Spire Southampton so cancer treatment and surgery could continue for patients at highest risk. We also increased the number of outpatient attendances which took place by telephone or video call, and our patient support hub was set up to provide a single point of support for patients who had been advised to shield. We are immensely proud of the record of the Trust during the pandemic, exemplified by the number of patients we were able to take into our care from well outside the local area. The Trust is in a strong financial position as a result of careful spending and efficiencies, which has allowed us to invest significantly in upgrading our estate. These improvements have seen the opening of the general intensive care unit, and the new cancer ward, which was built in just six months. These formed part of overall capital expenditure of £80 million during the year. The last year has seen us say goodbye to two members of our executive leadership team. Paula Head left the chief executive officer role in November to join the national response to COVID-19, before becoming a senior fellow at The King’s Fund. Derek Sandeman moved on from being our chief medical officer to take the same position at the Hampshire and Isle of Wight Integrated Care System. We are grateful to both for their efforts on the Trust leadership team during the most challenging of years. One of our non-executive directors, Jenni Douglas-Todd, also left the Trust to take on the important role of director of equality and inclusion with NHS England and NHS Improvement. 6 Looking ahead to the future, UHS will play a key role in the Hampshire and Isle of Wight Integrated Care System. Our commitment is to deliver services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries for seamless patient care. We as a Trust board are looking forward to implementing our own five year strategy, which sets out ambitions for what we want the hospital to be in 2025, for both patients and staff. Our focus will always be on enabling world class people to deliver world class care. Peter Hollins David French Chair Chief Executive Officer 7 OVERVIEW AND PERFORMANCE Performance report Introduction from our chief executive Over the last year, the way in which the Trust has worked and performance it has achieved, has been transformed by the COVID-19 pandemic. • UHS saw a number of large surges in demand for inpatient care, and for intensive respiratory support in particular, due to COVID-19 infection rates. Our capacity to deliver intensive care had to be increased, and many of our staff moved from other services such as our elective theatres in order to meet this need for care. • We have introduced and continue to maintain a number of changes to reduce the risk of COVID-19 being transmitted, or adversely affecting patient outcomes, within the Trust. Changes have included the wearing of additional personal protective equipment by our staff (especially when caring for patients who might have COVID-19 or undertaking higher risk procedures), reducing the number of patients coming to our outpatient departments and increasing the number of telephone and video consultations, separating elective and emergency patients within our departments and regular testing of our staff and all patients on or prior to their admission to hospital for treatment. • Public concerns about safety, government restrictions and the efforts of community services actually contributed to reductions in the total number of patients who sought hospital care this year. • Treatment plans have been modified by a number of services, in partnership with patients, to reduce the risk posed by COVID-19 to those patients. This was often appropriate in those circumstances in which the normal treatment would significantly reduce the patient’s own resistance to infections. Our performance has, in many cases, been strongly influenced by these profound changes. We have responded well to the need to provide the most urgent care, and the adverse impacts on elective care have been slightly less than the average across the NHS. However, we remain very concerned by the significant increase in the numbers of patients waiting longer than they should for elective care. It will take concerted and sustained action within both the Trust and the wider NHS in order to return elective performance to levels achieved before the pandemic whilst also continuing to meet urgent care needs as the restrictions that have been implemented within our society are progressively relaxed. 9 Overview About the Trust Our services University Hospital Southampton NHS Foundation Trust is one of the largest acute teaching trusts in England with a turnover of more than £1 billion in 2020/21. It is based on the coast in south east England and provides services to over 1.9 million people living in Southampton and south Hampshire and specialist services, including neurosciences, respiratory medicine, cancer care, cardiovascular, obstetrics and specialist children’s services, to more than 3.7 million people in central southern England and the Channel Islands. The Trust is also a designated major trauma centre, one of only two places in the south of England to offer adults and children full major trauma care provision. As a leading centre for teaching and research, the Trust has close working relationships with the University of Southampton, the Medical Research Council, National Institute for Health Research (NIHR), Wellcome Trust and Cancer Research UK. UHS is consistently one of the UK’s highest recruiting trusts of patients to clinical trials and in the top ten nationally for research study volume as ranked by the NIHR Clinical Research Network. 12,000 Every year over staff at UHS: treat around 160,000 inpatients and day patients, including about 75,000 emergency admissions see over 650,000 people at outpatient appointments deal with around 150,000 cases in our emergency department deliver more than 100 outpatient clinics across the south of England, keeping services local for patients The Trust provides most of its services from the following locations: • Southampton General Hospital – the Trust’s largest location, where a great number of specialist services are based alongside emergency and critical care and which includes Southampton Children’s Hospital. • Princess Anne Hospital – located across the road from Southampton General Hospital and providing maternity care and specialist care for women with medical problems during pregnancy and babies who need extra care around birth across the region. • Royal South Hants Hospital – although the Trust does not operate this site near the centre of Southampton it provides a smaller number of services from this location. • New Forest Birth Centre – located at Ashurst on the edge of the New Forest and run by experienced midwives and support staff it offers a safe, ‘home away from home’ environment for women having a healthy pregnancy and expecting a straightforward birth. The services provided by the Trust are commissioned and paid for by local clinical commissioning groups (CCGs) and, in the case of more specialised services (such as treatments for rare conditions), by NHS England. Over 50% of UHS services are paid for by CCGs and approximately 48% by NHS England. We provide these under a standard NHS contract, which incorporates ongoing monitoring of the Trust and the quality of the services provided. 10 Our structure UHS gained foundation trust status on 1 October 2011. A foundation trust is a public benefit corporation providing NHS services in line with the core NHS principles: that care should be universal, comprehensive and free at the point of need. The Trust is licensed as a foundation trust to provide these services by Monitor (the independent regulator, now part of NHS England and NHS Improvement) and the healthcare services we provide are regulated by the Care Quality Commission. Being a foundation trust has enabled greater local accountability and greater financial freedom and has supported the delivery of the Trust’s mission and strategy over a number of years. The diagram below provides an overview of the overall organisational structure of the Trust. Public and foundation trust members Council of Governors Board of Directors Executive Directors Division A Surgery Critical Care Opthalmology Theatres and Anaesthetics Division B Division C Cancer Care Emergency Medicine Helicopter Emergency Medical Services Medicine and Medicine for Older People Pathology Specialist Medicine Women and Newborn Maternity Child Health Clinical Support Division D Trust Headquarters Division Cardiovascular and Thoracic Neurosciences Trauma and Orthopaedics Radiology Corporate Affairs Communications Estates, Facilities and Capital Development Finance Human Resources Informatics Patient Support Services Procurement and Supply Transformation and Improvement (‘Always Improving’) Research and Development Strategy and Business Development 11 The Trust is also part of an integrated care system in Hampshire and the Isle of Wight, which is a partnership of NHS and local government organisations working together to improve the health and wellbeing of the population across Hampshire and the Isle of Wight. Our values Our values describe how we do things at UHS and act as a guide to all staff working with colleagues to deliver high quality patient care and a great patient experience every day. Our values are: Patients, their families and carers are at the heart of what we do. Their experience of our services will be our measure of success. Partnership between clinicians, patients and carers is critical to achieving our vision, both within hospital teams and extending across organisational boundaries in the NHS, social care and the third sector. We will ensure we are always improving services for patients through research, education, clinical effectiveness and quality improvement. We will continue to incorporate new ideas, technologies and create greater efficiencies in the services we provide. 12 Our strategy 2021-25 The Trust’s strategy was updated during 2020/2021 to take account of everything our staff had experienced during the COVID-19 pandemic and what we had learnt from this. The vision for UHS is to continue on its journey to become an organisation of world class people delivering world class care. Our strategy is organised around five themes and for each of these describes a number ambitions we aim to achieve by 2025. Theme Ambitions Outstanding patient outcomes, • We will monitor clinical outcomes, safety and experience of our experience and safety patients regularly to ensure they are amongst the best in the UK By 2025 we will strengthen our and the world. national reputation for outstanding • We will reduce harm, learning from all incidents through our patient outcomes, experience and proactive patient safety culture. safety, providing high quality care • We will ensure all patients and relatives have a positive experience and treatment across an extensive of our care, as a result of the environment created by our people range of services from foetal and our facilities. medicine, through all life stages and conditions, to end-of-life care. Pioneering research • We will recruit and enable people to deliver pioneering research and innovation in Southampton. We will continue to be a leading teaching hospital with a growing, reputable and innovative research and development portfolio • We will optimise access to clinical research studies for our patients. • We will enable innovation in everything we do, and ensure that ‘cutting edge’ investigations and treatments are delivered in Southampton. that attracts the best staff and efficiently delivers the best possible treatments and care for our patients. World class people • We will recruit and develop enough people with the right Supporting and nurturing our knowledge and skills to meet the needs of our patients. people through a culture that values • We will provide satisfying and fulfilling roles, growing our talent diversity and builds knowledge and through development and opportunity for progression. skills to ensure everyone reaches • We will empower our people, embracing diversity and embedding their full potential. We must provide compassion, inclusion and equity of opportunity. rewarding career paths within empowered, compassionate, and motivated teams. Integrated networks and collaboration We will deliver our services with partners through clinical networks, collaboration and integration across geographical and organisational boundaries. • We will work in partnership with key stakeholders across the Hampshire and Isle of Wight integrated care system. • We will strengthen our acute clinical networks across the region, centralising when necessary and supporting local care when appropriate. • We will foster local integration with primary and community care as well as mental health and social care services for seamless delivery across boundaries. • We will build on our successful partnership with University of Southampton (UoS), growing our reputation as a national leading university teaching hospital. 13 Theme Foundations for the future Making our enabling infrastructure (finance, digital, estate) fit for the future to support a leading university teaching hospital in the 21st century and recognising our responsibility as a major employer in the community of Southampton and our role in broader environmental sustainability. Ambitions • We will deliver best value to the tax payer as a financially efficient and sustainable organisation. • We will support patient self-management and seamless care across organisational boundaries through our ambitious digital programme, including real time data reporting, to inform our care. • We will expand and improve our estate, increasing capacity where needed and providing modern facilities for our patients and our people. • We will strengthen our role in the community as an employer of choice, a partner in delivery of services to our population and by leading the Greener NHS agenda locally. During each year of the strategy the Trust will set out a more detailed series of objectives to achieve and progress towards the delivery of its ambitions. In 2020/21 these objectives included: • Recovery, restoration and improvement of clinical services • Implementing the ‘Always Improving’ strategy • Restoring a full research portfolio • Continuing our focus on staff wellbeing including the long-term effects of coronavirus (long COVID) • Working in partnership with the newly established integrated care system • Creating a sustainable financial infrastructure • Making our corporate infrastructure (digital, estate) fit for the future to support a leading university teaching hospital in the 21st century, including an estates masterplan. Performance against these objectives will be monitored and reported to the Trust’s board of directors on a quarterly basis. Principal risks to our strategy and objectives The board of directors has identified and manages the principal risks to the delivery of its strategy and objectives through its board assurance framework. The principal risks to the delivery of its strategy and objectives identified by the Trust during 2020/21 were that: • it would be unable to form effective partnerships that achieve networked care for patients; • it could not develop the estate in line with the ambitions set out in the strategy; • it would fail to restore and increase capacity following the COVID-19 pandemic to meet waiting times for elective care and cancer care needs; • it would fail to introduce and implement new technology for the transformation of care; • it would be unable to retain, recruit, develop and train a diverse and inclusive workforce necessary to meet the strategic goals; • it could not develop a sustainable model within the new financial regime that preserves quality care; • it would fail to provide vulnerable service users with timely and high quality and appropriate care; • it would not reach the ambition of outstanding compliance and quality standards; • it could not sufficiently engage with key stakeholders and system partners to support effective interventions and maintain the health of the local population; • it would be unable to respond to the needs of the NHS in order to deliver our strategy; • it would fail to capitalise on its relationship with the universities in Southampton and other health education providers in line with our strategy; • it would not develop innovative education and training approaches. 14 While the COVID-19 pandemic presented the Trust with new risks as it introduced more stringent infection control processes, stopped certain types of activity and responded quickly to care for large numbers of seriously ill patients who had tested positive for COVID-19, it also prompted innovation across a wide range of areas. However the ongoing impact of the pandemic on both our staff, patients who have had COVID-19 and patients who have waited longer than expected for treatment as a result, added to the risks facing the Trust. National targets for performance have not been amended as a result of the pandemic, although the national plan has focussed on the recovery of activity levels as the first stage in a restoration of elective services. Capacity – The initial and subsequent waves of the COVID-19 pandemic have led to increases in the waiting times for patients and the number of patients waiting more than 52 and 78 weeks has increased significantly. While the Trust was able to recover capacity quickly between waves of the pandemic, its ability to reduce the overall waiting list and the length of time patients are waiting for treatment remains one of the key risks for the Trust. This may be compounded by the reduction in the number of referrals from GPs during the pandemic, leading to a potential future increase in the number of patients being referred as people visit their GPs for the first time with more advanced disease. During the pandemic the Trust utilised the support available from the independent sector to continue cancer treatment and surgery for those patients at highest risk. It also increased the number of outpatient attendances which took place by telephone or video call. The Trust developed a clinical assurance framework during the year to better assess the risk of harm to patients as a result of delays in treatment and this has been utilised in decision-making around the allocation of resources to those areas where there is the greatest risk of potential harm to patients. In addition to opening additional capacity during 2020/21 (described in the Estates section below), the Trust also committed expenditure and commenced construction works in 2020/21 in order to be in a position to open an additional endoscopy room and four further operating theatres during 2021/22 and prepared plans for a significant expansion in ophthalmology outpatient capacity. These initiatives will contribute to improvements in elective waiting times that needed following the pandemic. Quality and compliance – The Trust continued to monitor the quality of care delivered throughout 2020/21. During the COVID-19 pandemic the primary focus became infection prevention and control, with the launch of a successful COVID ZERO campaign that saw the Trust reduce the transmission of the virus in hospital (nosocomial transmission). The Trust also achieved its annual target for reduction in Clostridium Difficile infections, however, there was one MRSA Bacteraemia during March 2021, the only such event in 2020/21. The Trust continued to develop its proactive patient safety culture during 2020/21 with changes to the way in which patient safety incidents are investigated and the approval of its Always Improving strategy, which will be launched in 2021. Reporting and investigation of incidents continued during 2020/21. Partnerships – During 2020/21, the Trust and its partners worked together very effectively to discharge patients safely and provide ongoing support to patients who had tested positive for COVID-19, to ensure patients requiring urgent cancer treatment and surgery were able to continue their treatment in the independent sector and to develop a COVID-19 saliva testing pilot with the University of Southampton and local authorities. Work to respond to the COVID-19 pandemic, however, meant that as a system we were unable to progress the Hampshire and Isle of Wight strategic plan delivery at the pace we would have wanted or had set out to achieve, particularly the development of networks. Nonetheless the application for Hampshire and Isle of Wight to become an integrated care system was approved with effect from 1 April 2021. 15 Existing networks continued to develop and improve. The Trust also became the Wessex Cancer Surgical Hub during 2020 as a result of a national initiative with the aim of maximising the number of patients receiving curative surgery. Both the Wessex Cancer Alliance and the Trust ended the year as the second highest performing among their respective peers for cancer treatment. Workforce – While additional staff were recruited to specifically assist the Trust during the pandemic, the Trust continued to recruit nurses from overseas during 2020/21 meaning that the number of vacancies has reduced compared to the position prior to the pandemic. Changes to recruitment processes were approved in 2020/21 to improve the fairness, transparency and quality of these. The Trust also continued to work with its staff networks and specific focus groups to increase diversity in leadership roles. While workforce capacity continues to be one of the biggest challenges faced by the Trust, during 2020/21 our main focus has been on supporting our staff to respond to the COVID-19 pandemic and providing both the tools and time to help staff recovery. We are incredibly proud of the way that staff responded to the pandemic and continue to recognise this in whatever ways we can, however, we also want to ensure that staff continue to be able to contribute to patient care at their best and want to stay and develop with the Trust. Technology was also used at levels not previously achieved to continue to deliver training to staff and enable staff to work from home where possible, ensuring a safer environment for patients and staff in the hospitals. Estate – The Trust continued to invest in and develop its estate during 2020/21 including the opening a new general intensive care unit (GICU), a new operating theatre and a new cancer care ward, built in just six months. These were part of £80 million of capital expenditure in 2020/21. The Trust has also established a programme to reduce backlog maintenance in addition to continuing to add to and improve the environment in which services are provided to patients and the working environment for staff. Innovation and technology – There have been exceptional levels of achievement in relation to COVID-19 related research activity, including in partnership with the universities. You can read more about these from page 167 of the quality report. The board of directors also supported the funding of an expansion of research and innovation activity to allow the continued delivery of the Trust’s ambitions to innovate and improve and transform its services. Sustainable financial model – The Trust achieved its forecast breakeven position in 2020/21. Income was more predictable in 2020/21 as block contract arrangements were put in place in response to the COVID-19 pandemic and ensured that costs were covered. The Trust continues to maintain a strong cash position and to implement improvements and efficiency savings, allowing it to continue to invest in its services. 16 Summary of performance COVID-19 bed occupancy UHS has experienced two distinct peaks in inpatient care for patients with COVID-19 infection, with smaller numbers of patients continuing to receive care outside these peak times. Bed occupancy reached a maximum of 173 in the first peak in April 2020, and 322 in the second peak in January 2021. All bed types Intensive care/higher care beds 17 Emergency access through our emergency and eye casualty departments Public concerns about safety, government restrictions on the activities people were able to do, and the efforts of community services contributed to significant reductions in the total number of patients who presented to our departments. All patients presenting to the emergency department Many changes were introduced within our departments in the course of the year to ensure that emergency assessment and treatment could be provided safely, including wearing of protective equipment by staff and patients, providing care in separate areas for patients suspected or known to have COVID-19, and using rapid laboratory tests to identify infection and confirm/exclude COVID-19 as a cause. Emergency access performance (measured as the percentage of patients discharged from emergency department care or admitted to a hospital bed within four hours of arrival to the department) improved significantly in 2020/21 compared to previous years. The national target of 95% was not achieved, however, the performance of our departments compared favourably with the average for acute trusts in England. 18 Emergency access four hour performance 19 Elective Waiting times Demand We saw a significant reduction in the number of elective referrals to hospital in the early part 2020/21, though they had returned close to pre-pandemic levels by the end of the year. It is likely that this pattern relates to a range of factors including reluctance from members of the public to attend healthcare facilities at that time, changes to the ways in which primary care was accessed, and efforts made within primary and community to avoid hospital referrals needing to be made. Accepted referrals The number of patients referred to hospital with suspected cancer also reduced during 2020/21; 7% fewer patients were seen across the year as a whole, though referrals returned to pre-pandemic levels or higher from July 2020 onwards. Patients seen following ‘Two week wait’ urgent referral for suspected cancer 20 Activity UHS hospital appointments, diagnostic tests and elective admissions were all significantly reduced during 2020/21 due to the impact of COVID-19. • During periods of higher bed occupancy with COVID-19 it was necessary to significantly reduce the number of elective admissions undertaken in order that additional staff could work in intensive care. Less clinically urgent and therefore longer waiting patients were primarily those affected. • Throughout the year, additional infection prevention measures have reduced the number of patients that can be seen in each session, particularly when higher risk ‘aerosol generating’ procedures are planned, but also as a result of additional PPE being worn or to enable greater distancing of patients attending outpatient departments. UHS was offered additional capacity at local independent sector hospitals and used this effectively to minimise these adverse impacts. Approximately 30% of outpatient appointments are now undertaken by telephone or video, helping to maintain the capacity for patient care whilst reducing the infection risk for those patients and helping to maintain distancing measures for those patients still attending our outpatient departments. The graphs below show 2020/21 activity levels as a percentage of those achieved in the previous year. Elective admissions (including daycase) 21 Outpatient attendances Performance The average waiting time for first outpatient appointments has remained close to nine weeks for the majority of the year. UHS has however experienced very significant deteriorations in the waiting times our patients experience for diagnostic tests to be undertaken and elective treatment to be provided. The reduced number of new patients referred to hospital early in 2020/21 has moderated the extent of the growth in the total numbers of patients waiting, and the greatest rate of growth has unfortunately been amongst those groups of patients already waiting longest. 22 Diagnostics Our performance measures for diagnostics report on a total of 15 different frequently used tests. The waiting list is approximately 50% bigger than it was before the pandemic and stable through the second half of the year. At the end of the year 28% of patients were waiting more than six weeks to receive their investigation compared to the national target of 1%. The tests with the largest numbers of longer waiting patients include non-obstetric ultrasound, MRI and endoscopies, and further recovery will be driven through a combination of recruitment, independent sector capacity and an additional endoscopy room which opened at the start of April 2021. Patients waiting for a diagnostic test to be performed (sum of 15 different frequently used tests) Percentage of patients waiting over 6 weeks for a diagnostic test to be performed 23 Referral to Treatment Our waiting list from referral to treatment increased in size by 6% (2,220 patients) during 2020/21, rising when the recovery in referral numbers exceeded the recovery in clinical activity, the total increase in waiting list size would have been significantly higher had it not been for the significant reduction in the referrals received by the hospital especially during the early months of the pandemic. Looking forward, we anticipate referrals numbers returning to pre-pandemic levels, and being able to maintain the total size of our waiting list by delivering an equivalent number of treatments each month. Number of patients waiting between referral and commencement of a treatment for their condition The national target is that at least 92% of patients should be waiting for treatment no more than 18 weeks from their referral to hospital. Our performance against this measure is now 12% worse than one year ago, at 66%. Our performance continues to be typical of the major teaching hospital trusts that we benchmark with and the trend has been similar to that experienced across trusts in England. Percentage of patients waiting up to 18 weeks between referral and treatment 24 Unfortunately, the number of patients waiting significantly longer than the 18 week target has increased at a faster rate than the size of the waiting list as a whole. The graph below shows how the percentage of patients who have waited more 52 weeks increased. The number of patients who have waited more 52 weeks increased from 40 in March 2020 to 3,419 by March 2021 (of these 445 patients had waited more than 78 weeks). Such patients often require surgical treatment, particularly in the orthopaedic, ear nose and throat and oral surgery specialities. The impact on surgical care has been greater than that in outpatients during the pandemic, and it is also more challenging to increase capacity due to the need for additional operating theatres and a combination of different healthcare professionals to work within them. UHS opened an additional operating theatre in 2020/21, and has a further four theatres scheduled to open during 2021/22, which will make a significant contribution to our capacity to treat more patients. Unfortunately, the number of patients waiting significantly longer than the 18 week target is likely to continue to grow further in the short term, due to diagnostic investigations having been progressed less quickly than usual during the pandemic, the need to prioritise our increased treatment capacity according to the clinical urgency of conditions and because our scheduled capacity increases will not be completed before the autumn of 2021. Percentage of patients waiting more than 52 weeks, between referral and commencement of a treatment for their condition 25 Cancer Waiting Times UHS has been mostly successful in maintaining the timeliness of urgent services for patients with suspected cancer through the pandemic, and our performance has been amongst the best in both the south-east and nationally. UHS prioritised the theatre and intensive care capacity we were able to provide during the pandemic in order to meet the needs of those patients with the greatest clinical urgency, used capacity offered by independent sector hospitals to supplement that available within NHS, and operated a hub through which hospitals in Wessex were able to collaborate to continue critical cancer surgery during periods of peak COVID-19 demand. The national target is to provide the first definitive treatment to at least 85% of patients with cancer with 62 days of referral to hospital. Whilst UHS performance remained below this level in the majority of months, our performance has been significantly better than the national average, and has improved relative to other trusts. Treatment for Cancer within 62 days of an urgent GP referral to hospital 26 The national target is to provide the first definitive treatment to at least 96% of patients within 31 days of a decision to treat being made and agreed with the patients; both for the first and any subsequent treatments for cancer. UHS achieved this level on average across the year, and in the majority of months. The treatments provided are typically by means of surgery, chemotherapy/immunotherapy or radiotherapy. The most significant performance challenge this year has been in radiotherapy, where more sophisticated treatment plans improve patient outcomes but take longer to prepare, and there was also reduced treatment capacity whilst we replaced one of our ‘Linear Accelerator’ treatment machines with a new model. First definitive treatment for cancer within 31 days of a decision to treat Equality in service delivery Identifying and addressing health inequalities have been the central part of the Trust’s approach to improving the experience of care for our patients, families and carers. Over the past year, new initiatives have augmented progress on existing work to ensure there is appropriate support, due regard and recognition of those patients and their families and carers who are most at risk of poor experiences, outcomes and access to services. In 2020 we added two questions to our patient surveys, asking first if patients felt themselves to have a disability or require a reasonable adjustment, and, if yes, whether the Trust met this need. In 2020/21, the results were: TOTAL Had a disability / required a reasonable adjustment 27% Had this need met by the Trust (positive response) 95% This question was added to our major Friends and Family Test surveys as well as our local service-specific patient surveys. In June 2020 the Trust launched the sunflower lanyard scheme for hidden disabilities, participating in the national initiative to ensure that people whose disabilities are not visible are able to access further support and reasonable adjustments by means of a nationally recognised indicator (the sunflower). In 2020/21, 618 lanyards were issued with those needs recorded to ensure future reasonable adjustments are made for those individuals. 27 Carers have always been essential partners in the care that we provide, and having introduced a new post at the end of 2019 to focus solely on carer experience, this work has culminated in a Trust strategy for improving the involvement, support and experience carers have of our services. We have, over the past year, introduced carers cards, virtual peer support and carer-specific information about services while actively participating in local and regional work on carers. In January 2021 we realised our ambition of becoming an accredited ‘Veterans Aware’ hospital, with our submission of evidence being recognised as ‘strong’ and indicative of an organisation that has made great progress in helping to provide enhanced support for the armed forces community. Towards the end of 2019 we worked with the disability organisation AccessAble to produce accessibility guides for all of our services and estate. These online guides allow patients and visitors with disabilities to plan their journey and identify potential challenges to the environment. In 2020/21 our guides had 5,000 unique visits per month. One of our COVID-19 initiatives, a patient support hub, was set up in May 2020 to provide a single point of support for our patients who had been advised to shield. The service has grown and now offers support to patients and carers who are vulnerable, disabled or with additional needs. This includes coordinating community transport, arranging companions to assist with attending appointments, hosting a technology library to support those who are digitally excluded in accessing virtual appointments and information, and most recently receiving funding to pilot volunteer-led support for diabetes patients. Across the Trust, we continue to actively promote the importance of asking patients and carers about disabilities and reasonable adjustments, flagging needs on our patient administrative system to prompt our services to take proactive steps to ensure that any needs or adjustments are met on each and every visit. This has been of vital importance for meeting accessible information and communication needs. We are currently one of first trusts to pilot a new translation app that provides immediate interpretation into different languages, and we have worked closely with our communication support partners to ensure that where virtual appointments are needed, people with communication needs (BSL, foreign language) are supported to access care virtually. Our specialist nursing liaison teams continued to support access to services throughout the pandemic, ensuring that patients with dementia, with learning disabilities and autism, were supported to attend hospital where necessary. Further information about the Trust’s work in relation to equality, diversity and inclusion can be found on page 69 and pages 106 and 160 in the quality report. Going concern After making enquiries, the directors have a reasonable expectation that the services provided by the Trust will continue to be provided by the public sector for the foreseeable future. For this reason, the directors have adopted the going concern basis in preparing the accounts, following the definition of going concern in the public sector adopted by HM Treasury’s Financial Reporting Manual. David French Chief Executive Officer 28 June 2021 28 Accountability report Directors’ report Board of directors The board of directors is usually made up of six executive directors and seven non-executive directors, including the chair. Since 1 January 2021 the number of non-executive directors has been reduced by one as Jane Bailey’s reappointment as a non-executive director was deferred to allow her to lead the Hampshire and Isle of Wight saliva mass testing programme. Jane is expected to return to the board of directors in her non-executive director role by 1 July 2021. Paragraph B.1.2 of the NHS foundation trust code of governance provides that at least half the board of directors, excluding the chair, should comprise non-executive directors determined by the board to be independent. Pending the reappointment of Jane Bailey as a non-executive director, the Trust has been operating with one fewer non-executive directors than is required by the Trust’s constitution and the Trust has been non-compliant with this paragraph of the code. During this period the provisions of the Trust’s constitution that a quorum for meetings of the board of directors requires at least one non-executive director and one executive director to be present and for the chair to have a second and casting vote in the case of an equal vote continued to apply. The board of directors has given careful consideration to the range of skills and experience it requires to run the Trust. Together the members of the board of directors bring a wide range of skills and experience to the Trust, such that the Board achieves balance and completeness at the highest level. The chair was determined to be independent on his appointment and the other non-executive directors have been determined to be independent in both character and judgement. This included specific consideration of Jane Bailey’s continued independence following her role leading the Hampshire and Isle of Wight saliva mass testing programme. The chair, executive directors and non-executive directors have declared any business interests that they have. Each director has declared their interests at public meetings of the board of directors. The register of interests is available on the Trust’s website. 30 The current members of the board of directors are: Non-executive directors Peter Hollins Chair Peter graduated in chemistry from Hertford College, Oxford. Joining Imperial Chemical Industries in 1973, he undertook a series of increasingly senior roles in marketing and then general management. Following three years in the Netherlands as general manager of ICI Resins BV, in 1992 he was appointed as chief operating officer of EVC in Brussels – a joint venture between ICI and Enichem of Italy. He played a key role in the flotation of the company in 1994, before returning in 1998 to the UK as chief executive officer of British Energy where he remained until 2001. From 2001, he held various chairmanships and non-executive directorships. In 2003, he decided to return to an executive role as chief executive of the British Heart Foundation in which post he remained until retirement in March 2013. He joined Southampton University Hospital Trust as a non-executive director in 2010, became senior independent director and deputy chairman of UHS in 2014 and was appointed chair in April 2016. Trust roles: • Chair of remuneration and appointment committee • Chair of governors’ nomination committee Jane Bailey Non-executive director In 1985, Jane joined the pharmaceutical company Glaxo as a management trainee, having graduated from London University with a degree in environmental science and pharmacology. Here she rose to senior commercial vice-president, gaining experience of a broad range of disease areas across different regions of the world. She specialised in leading global research and development teams in the formation of strategies to bring new medicines to patients. She also worked to ensure that the medicines developed were supported by robust evidence demonstrating their clinical and cost-effectiveness. In delivering this she gained extensive experience of leading large diverse teams across a complex global organisation. For five years, Jane ran her own strategy development consultancy, working across a breadth of healthcare organisations. In 2017 Jane gained an MSc in public health, with distinction, at King’s College, London University. Her studies focused on how to ensure the public are engaged in development of healthcare services and how social theories can help inform effective disease prevention and management. Jane is a director of Wessex NHS Procurement Limited, a joint venture between the Trust and Hampshire Hospitals NHS Foundation Trust and a director of Healthwatch Portsmouth. Trust roles: • Deputy chair and senior independent director • Chair of finance and investment committee • Audit and risk committee member • Charitable funds committee member • People and organisational development committee member • Remuneration and appointment committee member • Wellbeing Guardian 31 Non-executive directors Dave Bennett Non-executive director Dave graduated in chemistry from the University of Southampton before entering management consulting, becoming a partner in Accenture’s strategy practice. In 2003 he joined Exel Logistics (later acquired by DHL), managing the company’s healthcare business across Europe and the Middle East. During this time, he established NHS Supply Chain, a UK organisation responsible for procuring and delivering medical consumables for the NHS in England, as well as sourcing capital equipment. Dave joined the board of Cable & Wireless as sales director in 2008. He later set up his own strategy consulting practice serving the healthcare sector, completing numerous projects in the UK and the US. Dave has also served as a non-executive director at The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust between 2009 and 2016, where he chaired the Trust’s quality committee. Dave is a non-executive director at the Faculty of Leadership and Medical Management and a director of Royal College of General Practitioners (RCGP) Enterprises Ltd and RCGP Conferences Ltd. Trust roles: • Chair of charitable funds committee • Chair of finance and investment committee (from 1 January 2021) • Audit and risk committee member (from 9 February 2021) • Quality committee member • Remuneration and appointment committee member • Chair of Trust’s organ donation committee 32 Non-executive directors Cyrus Cooper Non-executive director Cyrus Cooper is professor of rheumatology and director of the MRC Lifecourse Epidemiology Unit. He is also vice-dean of the faculty of medicine at the University of Southampton and professor of epidemiology at the Nuffield Department of Orthopaedics (rheumatology and musculoskeletal sciences, University of Oxford). He leads an internationally competitive programme of research into the epidemiology of musculoskeletal disorders, most notably osteoporosis. His key research contributions have been: • discovery of the developmental influences which contribute to the risk of osteoporosis and hip fracture in late adulthood • demonstration that maternal vitamin D insufficiency is associated with sub-optimal bone mineral accrual in childhood • characterisation of the definition and incidence rates of vertebral fractures • leadership of large pragmatic randomised controlled trials of calcium and vitamin D supplementation in the elderly as immediate preventative strategies against hip fracture. He is president of the International Osteoporosis Foundation, chair of the BHF Project Grants Committee, an emeritus NIHR senior investigator, a director of The Rank Prize Funds and associate editor of Osteoporosis International. He has previously served as chairman of the Scientific Advisors Committee (International Osteoporosis Foundation), the MRC Population Health Sciences Research Network and the National Osteoporosis Society of Great Britain. He has also been president of the Bone Research Society of Great Britain and has worked on numerous Department of Health, European Community and World Health Organisation committees and working groups. Cyrus has published extensively on osteoporosis and rheumatic disorders and pioneered clinical studies on the developmental origins of peak bone mass. In 2015, he was awarded an OBE for services to medical research. Trust roles: • Quality committee member • Remunerati
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Annual-reports-and-quality-accounts/annual-report-20-21.pdf

Papers Trust Board - 25 July 2024

Description: Agenda Trust Board – Open Session Date 25/07/2024 Time 9:00 - 13:00 Location Anaesthetic Seminar Room (CE95/99), E Level, Centre Block, SGH/ Microsoft Teams Chair Jenni Douglas-Todd Apologies Gail Byrne (Natasha Watts to deputise) In attendance Kerrie Montoute, Head of Programmes, CDO Directorate at NHSE (shadowing Jenni Douglas-Todd) 1 9:00 2 3 9:15 4 5 5.1 9:20 5.2 9:25 5.3 9:30 5.4 9:35 5.4.1 Chair’s Welcome, Apologies and Declarations of Interest Note apologies for absence, and to hear any declarations of interest relating to any item on the Agenda. Patient Story The patient story provides an opportunity for the Board to reflect on the experiences of patients and staff within the Trust and understand what the Trust could do better. Minutes of Previous Meeting held on 6 June 2024 Approve the minutes of the previous meeting held on 6 June 2024 Matters Arising and Summary of Agreed Actions To discuss any matters arising from the minutes, and to agree on the status of any actions assigned at the previous meeting. QUALITY, PERFORMANCE and FINANCE Quality includes: clinical effectiveness, patient safety, and patient experience Briefing from the Chair of the Audit and Risk Committee (Oral) Keith Evans, Chair Briefing from the Chair of the Finance and Investment Committee (Oral) Dave Bennett, Chair Briefing from the Chair of the People and Organisational Development Committee (Oral) Jane Harwood, Chair Briefing from the Chair of the Quality Committee (Oral) Tim Peachey, Chair Maternity and Neonatal Safety 2024-25 Quarter 1 Report 5.5 Chief Executive Officer's Report 9:45 Receive and note the report Sponsor: David French, Chief Executive Officer 5.6 Performance KPI Report for Month 3 10:15 Review and discuss the report Sponsor: David French, Chief Executive Officer 5.7 Break 10:45 5.8 Finance Report for Month 3 11:00 Review and discuss the report Sponsor: Ian Howard, Chief Financial Officer 5.9 People Report for Month 3 11:15 Review and discuss the report Sponsor: Steve Harris, Chief People Officer 5.10 Annual Complaints Report 2023-24 11:30 Receive and discuss the report Sponsor: Gail Byrne, Chief Nursing Officer Attendee: Natasha Watts, Interim Deputy Chief Nursing Officer 6 STRATEGY and BUSINESS PLANNING 6.1 Corporate Objectives 2024-25 Quarter 1 Review 11:45 Review and feedback on the corporate objectives Sponsor: David French, Chief Executive Officer Attendees: Martin De Sousa, Director of Strategy and Partnerships/Kelly Kent, Head of Strategy and Partnerships 6.2 Research and Development Plan 2024-25 12:00 Discuss and approve the plan Sponsor: Paul Grundy, Chief Medical Officer Attendees: Karen Underwood, Director of R&D/Marie Nelson, R&D Head of Nursing and Health Professions 6.3 Board Assurance Framework (BAF) Update 12:20 Review and discuss the update Sponsor: Gail Byrne, Chief Nursing Officer Attendees: Craig Machell, Associate Director of Corporate Affairs and Company Secretary/Lauren Anderson, Corporate Governance and Risk Manager Page 2 7 CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors' Meeting 24 July 2024 (Oral) 12:30 Sponsor: Jenni Douglas-Todd, Trust Chair 7.2 Register of Seals and Chair's Actions Report 12:35 Receive and ratify In compliance with the Trust Standing Orders, Financial Instructions, and the Scheme of Reservation and Delegation. Sponsor: Jenni Douglas-Todd, Trust Chair 8 Any other business 12:40 Raise any relevant or urgent matters that are not on the agenda 9 Note the date of the next meeting: 10 September 2024 10 Resolution regarding the Press, Public and Others Sponsor: Jenni Douglas-Todd, Trust Chair To agree, as permitted by the National Health Service Act 2006 (as amended), the Trust's Constitution and the Standing Orders of the Board of Directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. 11 Follow-up discussion with governors 12:45 Page 3 Minutes Trust Board – Open Session Date 06/06/2024 Time 9:00 – 13:00 Location Conference Room, Heartbeat/Microsoft Teams Chair Jenni Douglas-Todd (JD-T) Present Gail Byrne, Chief Nursing Officer (GB) Keith Evans, Deputy Chair and NED (KE) David French, Chief Executive Officer (DAF) Paul Grundy, Chief Medical Officer (PG) Steve Harris, Chief People Officer (SH) Jane Harwood, NED/Senior Independent Director (JH) Ian Howard, Chief Financial Officer (IH) Tim Peachey, NED (TP) (until 12:00) Joe Teape, Chief Operating Officer (JT) In attendance Craig Machell, Associate Director of Corporate Affairs and Company Secretary (CM) Lauren Anderson, Corporate Governance and Risk Manager (LA) (item 6.3) Christine Mbabazi, Equality & Inclusion Advisor/Freedom to Speak Up Guardian (CM) (item 5.12) Jenny Milner, Associate Director of Patient Experience (JM) (item 5.11) Suzy Pike, Divisional Director of Nursing/Professions, Division B (SP) (item 5.13) Clare Rook, Chief Operating Officer, CRN: Wessex (CR) (item 6.1) Julian Sutton, Interim Lead Infection Control Director (JS) (item 5.10) 1 member of the public (item 2) 5 governors (observing) 6 members of staff (observing) 2 members of the public (observing) Apologies Dave Bennett, NED (DB) Diana Eccles, NED (DE) Alison Tattersall, NED (AT) 1. Chair’s Welcome, Apologies and Declarations of Interest The Chair welcomed attendees to the meeting. There were no interests to declare in the business to be transacted at the meeting. It was noted that apologies had been received from Diana Eccles, Alison Tattersall and Dave Bennett. The Chair provided an overview of her activities since April 2024, including visits to hospital departments, meetings with peers and other key stakeholders. 2. Patient Story Hannah Pilka was invited to relate the story of her father, Karol Pilka, who died suddenly in hospital on 31 December 2023. The care and compassion shown by the nurse caring for Karol Pilka was highlighted. This greatly assisted the family with the grieving process. The Trust’s bereavement team was also praised. The Board noted the importance of care and compassion by the Trust’s staff. Page 1 3. Minutes of the Previous Meeting held on 28 March 2024 The draft minutes tabled to the meeting were agreed to be an accurate record of the meeting held on 28 March 2024. 4. Matters Arising and Summary of Agreed Actions It was noted there were no matters arising or overdue actions. 5. QUALITY, PERFORMANCE and FINANCE 5.1 Briefing from the Chair of the Audit and Risk Committee The chair of the Audit and Risk Committee was invited to provide an overview of the meeting held on 20 May 2024. It was noted that: • The committee reviewed the Trust’s National Cost Collection submission for 2023/24. • A report on waivers of competitive tendering was received, and it was noted that these were mostly due to urgent requirements or where there was only a single supplier. • The committee reviewed the Trust’s draft Annual Report and Accounts for 2023/24. • The draft internal audit report for 2023/24 was expected to provide a ‘clean’ opinion and there were no outstanding actions from previous audits. • The Trust received a ‘green’ assessment from the review against the Counter- Fraud Functional Standard. 5.2 Briefing from the Chair of the People and Organisational Development Committee The chair of the People and Organisational Development Committee was invited to provide an overview of the meeting held on 22 May 2024. It was noted that: • The committee reviewed the People Report for Month 1 (item 5.9) and noted that performance in this area was positive. • The additional workforce controls appeared to be working in terms of managing the size and composition of the Trust’s workforce. • The controls in respect of use of bank and agency staff also appeared to have had a significant effect. • The committee received an update on the Trust’s Inclusion and Belonging Strategy, noting that a number of initiatives were underway. • The committee reviewed progress against the objectives for year three of the Trust’s People strategy and expressed concern with the level of resource available to deliver these. 5.3 Briefing from the Chair of the Finance and Investment Committee The chair of the Finance and Investment Committee was invited to provide an overview of the meeting held on 3 June 2024. It was noted that: • The committee reviewed the Finance Report for Month 1 (item 5.7) and received an update in respect of the Trust’s annual plan for 2024/25. • The committee received an update on the Trust’s Cost Improvement Programme, noting that it had achieved £2.5m to date out of the £82m target. • UHS Estates was broadly on budget and was delivering and a positive report was also noted in respect of Wessex Procurement Limited. Page 2 5.4 Briefing from the Chair of the Quality Committee The chair of the Quality Committee was invited to provide an overview of the meeting held on 3 June 2024. It was noted that: • The committee noted an increase in the number of high-harm falls, which was a concern. • The committee also expressed concern at the resource demand posed by Inquests and post-mortems, particularly in terms of the number of witnesses now being called by Coroners. • The committee had reviewed a draft of the Trust’s Quality Account for 2023/24. • In reviewing the relative risk of mortality, it was noted that patients were 16% less likely to die at the Trust compared to the average mortality rate. • In terms of infection prevention and control, it was noted that this was at a higher rate than was acceptable, although there was a national issue in terms of infection prevention and control (item 5.10). 5.5 Chief Executive Officer’s Report David French was invited to present the Chief Executive Officer’s Report, the content of which was noted. It was further noted that: • It was the 80th anniversary of Operation Overlord, the Allied landings in Normandy. • The Infected Blood Inquiry had published its report on 20 May 2024. As a result of which, the UK Government has established a compensation scheme for those impacted. In addition, NHS England had commissioned an ongoing patient support service for those affected, and it was expected that the Trust would be one of the two providers in the region offering this service. • The Prime Minister had announced that a general election would be held on 4 July 2024. As a result, there were a number of implications for the Trust as a public body during the ‘pre-election period’. • Further industrial action by junior doctors was scheduled to take place between 27 June 2024 and 2 July 2024. The Trust was taking appropriate steps to manage this. • Paula Melhuish, Deputy Director of Estates and Capital Development, had received the Outstanding Service Award from the Health Estates and Facilities Management Association on 13 May 2024. • The Trust had been awarded additional capital funding due to its Emergency Department performance at the end of 2023/24. It was likely that some of this funding would be used to increase same-day emergency care capacity. • The Trust’s plan for 2024/25 had yet to be agreed in common with other trusts across NHS England. • Discussions were ongoing in respect of the Integrated Care Board’s transformation programmes, and it was noted that David French had been appointed to head the workforce transformation programme. 5.6 Performance KPI Report for Month 1 Joe Teape was invited to present the Performance KPI Report for Month 1, the content of which was noted. It was further noted that: • The data for March 2024 showed that the Trust was in the top-half or top- quarter in terms of its comparative performance. • There were 15 patients waiting longer than 78 weeks for a corneal transplant due to a lack of available materials beyond the Trust’s control. • Emergency Department performance had improved during May 2024 with use of surge capacity of only 14 per day (out of 50) and a reduction in the number Page 3 of patients with no criteria to reside of about 10%, although this was mostly due to the time of the year. • The Trust’s Diagnostics performance had been good over the period, with all but two areas achieving the 95% target. Recovery plans were in place for the areas not achieving the target and the Trust had informed trusts with cardiac magnetic resonance imaging capability that referrals would no longer be supported. • The Trust’s overall key performance indicators showed good or improving performance. However, there were concerns about the sustainability of this trajectory and some areas were vulnerable to loss of key personnel. • The Quality Committee was to carry out a deep-dive into falls and pressure ulcers, and a hydration trial to reduce the number of falls was being considered. The Board noted the reported ransomware attack against Synnovis on 3 June 2024, which had impacted trusts in London as well as the NHS Blood and Transplant service. It was noted that the Trust did use the supplier, but was unaffected by the incident. However, the impact on the NHS Blood and Transplant service would likely cause potential issues for the Trust in terms of the availability of blood and transplant services. Action: JT agreed to include Digital as an agenda item at a future Trust Board Study Session. 5.7 Finance Report for Month 1 Ian Howard was invited to present the Finance Report for Month 1, the content of which was noted. It was further noted that: • Planning for 2024/25 was still ongoing, and a further submission was to be made on 12 June 2024. As a result of the delays in the planning process, there was currently no formal reporting to NHS England. • The Trust had recorded a deficit of £3.8m during the month, which was in line with its current plan. • The Trust’s underlying deficit was between £4-4.5m per month. However, during month 1, this was nearer to £6m due to lower elective recovery performance during the period. 5.8 Break 5.9 People Report for Month 1 Steve Harris was invited to present the People Report for Month 1, the content of which was noted. It was further noted that: • There had been an overall reduction in whole-time equivalents during April 2024, with a reduction in bank and agency use. It was noted that 60-80 agency staff were related to patients with a mental health-related care need. • The Trust’s annual workforce plan had been submitted, but this was reliant on delivery by the Integrated Care System on a number of assumptions in terms of patients with no criteria to reside and provision of mental health care. • The Trust had received a silver award under the Defence Employer Recognition Scheme. Page 4 • The Trust was the second-lowest user of bank and agency staff in the southeast region. This represented a significant turnaround within a short period, although it was noted that there were some areas of fragility within the Trust. 5.10 Infection Prevention and Control 2023-24 Annual Report Julian Sutton was invited to present the Infection Prevention and Control 2023/24 Annual Report, the content of which was noted. It was further noted that: • There were a number of concerns stemming from application of ‘fundamentals of care’, such as a failure to apply risk reduction measures appropriately. • There had been seven cases of Methicillin-resistant Staphylococcus aureus (MRSA) during the year. • An update was provided in respect of the candida aureus outbreak, with approximately 70 patients colonised. • Rapid upper gastro-intestinal tract testing had resulted in benefits due to the speed of detecting infections and/or ruling them out quicker, thereby freeing up capacity. • An update was provided in respect of the incidence of measles since April 2024, which necessitated a significant amount of work to carry out contact tracing and to notify those potentially exposed. • There was a general increase in the infection rate nationally, and the Trust generally was in the middle in terms of its performance, dependent on the particular infection category. 5.11 Learning from Deaths 2023-24 Quarter 4 Report Jenny Milner and Paul Grundy were invited to present the Learning from Deaths report for Quarter 4, the content of which was noted. It was further noted that: • In line with a national trend, there had been an increase in the number of deaths during the fourth quarter. • A new application was being trialled to facilitate the sharing of the learnings from morbidity and mortality meetings. Work was also being carried out to standardise morbidity and mortality meetings, which would further facilitate the dissemination of learning. • Due to performance by the current provider below the standard expected, the Trust was tendering for a new supplier for baby funerals. • The Medical Examiner service was prepared for the changes due to be implemented nationally in September 2024 requiring the review of all deaths. • Based on the whole-year average, the Trust had the fifth-lowest mortality rate in England. • The Trust’s bereavement service had some constraints on resources, which was impacting out-of-hours and weekend support. 5.12 Freedom to Speak Up Report Christine Mbabazi was invited to present the Freedom to Speak Up Report, the content of which was noted. It was further noted that: • Between the period November 2023 – May 2024, the Trust had recorded 56 Freedom to Speak Up cases, compared to 44 during the same period in 2022/23. Page 5 • The reintroduction of face-to-face meetings following the COVID-19 pandemic had resulted in quicker resolution of issues. • The Trust was moving away from the term ‘whistleblowing’ owing to the possible negative connotations of the term, in favour of ‘speaking up’. • Investigations into cases raised via the Trust’s Freedom to Speak Up service always had involvement by an individual who was independent. • There was an issue with complaints found to be untrue where the complainant was anonymous and how to handle these cases, especially in terms of where an individual was subject to an unfounded allegation of wrongdoing. • The cases raised were similar in terms of the themes as the rest of the country. • Freedom to Speak Up should be a last resort, where possible, concerns should be dealt with at the local level. • Although most cases were resolved satisfactorily, communicating the outcome could be a challenge due to the need to preserve confidentiality in respect of matters such as disciplinary processes. • Support was provided to the Trust’s Freedom to Speak Up champions, including mental health/wellbeing support where appropriate. 5.13 Fuller Inquiry Report Suzi Pike was invited to present the Fuller Inquiry Report, the content of which was noted. It was further noted that in November 2021, an independent inquiry was established to investigate how an NHS estates member of staff was able to carry out inappropriate and unlawful actions in the mortuary of Maidstone and Tunbridge Wells NHS Trust, and how and why this activity went unnoticed for so long. The inquiry was split into two phases, and this report was to provide detail of the 17 recommendations arising from the inquiry’s phase one report and the Trust’s response to these. 6. STRATEGY and BUSINESS PLANNING 6.1 CRN Wessex 2023-24 Annual Performance Report Clare Rook and Paul Grundy were invited to present the CRN Wessex 2023/24 Annual Performance Report, the content of which was noted. It was further noted that: • The network was assessed against three high-level objectives concerning recruitment onto commercial and non-commercial studies and experience survey participation rates. • The network did not meet the objective in respect of open studies, but was close to the target for non-commercial studies. The network did achieve the experience survey participation objective. • The changes in the research network were expected to result in positive opportunities, although were consuming significant amounts of time managing the HR aspects of the transition. Page 6 6.2 Board Assurance Framework (BAF) Update Lauren Anderson was invited to present the Board Assurance Framework (BAF) update, the content of which was noted. It was further noted that: • The BAF had been reviewed and updated since it was last presented to the Board in March 2024. • The likelihood rating of the Estates risk (risk 5b) had increased, resulting in an increase from 16 to 20. • Work was being carried out to further embed the Trust’s risk appetite and to link the Trust’s operational risks with the BAF. This included consideration of the creation of an intermediate, division-level risk register in order to bridge the gap between the operational and BAF risks. 7. CORPORATE GOVERNANCE, RISK and INTERNAL CONTROL 7.1 Feedback from the Council of Governors’ (CoG) Meeting 1 May 2024 The Chair provided an overview of the Council of Governors’ meeting held on 1 May 2024. It was noted that the Council of Governors had considered the following matters: • A report from the Chief Executive Officer • The Trust’s 2024/25 corporate objectives • Non-NHS activity • The annual report and quality account timetable • Terms of Reference • Governor vacancies and elections • Membership engagement 7.2 Register of Seals and Chair’s Actions Report The paper ‘Register of Seals and Chair’s Actions Report’ was presented to the meeting, the content of which was noted. Decision: The Board agreed to ratify the application of the Trust Seal to the documents listed in the ‘Register of Seals and Chair’s Actions Report’. 8. Any other business There was no other business. 9. Note the date of the next meeting: 25 July 2024 10. Resolution regarding the Press, Public and Others Decision: The Board resolved that, as permitted by the National Health Service Act 2006 (as amended), the Trust’s Constitution and the Standing Orders of the board of directors, that representatives of the press, members of the public and others not invited to attend to the next part of the meeting be excluded due to the confidential nature of the business to be transacted. The meeting was adjourned. Page 7 List of action items Agenda item Assigned to Deadline Status Trust Board – Open Session 28/03/2024 4.14 Guardian of Safe Working Hours Quarterly Report 1127. Junior Doctors Grundy, Paul Hulbert, Diana 24/10/2024 Pending Explanation action item Paul Grundy and Diana Hulbert agreed to include an item regarding junior doctors on a future Trust Board Study Session agenda. Update: Due to industrial action on 27 June, this item has been deferred to the next TBSS on 24/10/2024. Trust Board – Open Session 06/06/2024 5.6 Performance KPI Report for Month 1 1152. Digital Teape, Joe 24/10/2024 Explanation action item JT agreed to include Digital as an agenda item at a future Trust Board Study Session. Pending Update: This item is tentatively scheduled for TBSS on 24/10/2024. Page 1 of 1 Report to the Trust Board of Directors Title: Agenda item: Sponsor: Author: Date: Purpose: Issue to be addressed: Maternity & Neonatal (MatNeo) Safety Report 2024-25 Quarter 1 (Qtr.1) 5.4.1 Gail Byrne, Chief Nursing Officer Emma Northover, Director of Midwifery and Professional Lead for Neonatal Services Jess Bown, Quality & Safety Midwifery Matron Hannah Mallon, Quality & Safety Neonatal Matron Marie Cann, MatNeo Safety Lead 25 July 2024 Assurance or reassurance  Approval Ratification Information  This report constitutes the agreed Maternity & Neonatal (MatNeo) Services Qtr.1 safety report, provides a key overview of our services in, providing assurance to the members for the following: 1. Perinatal Quality Surveillance Qtr.1 (Appendix 1) 2. Serious Incidents (Appendix 2), Learning Slide (Appendix 2a) 3. Perinatal Mortality Review Tool (PMRT) (Appendix 3) 4. ATAIN Qtr.1 Report (Appendix 4) 5. Quality & Safety Shared Learning Slide (Appendix 5 MNSI QRM) 6. Culture Score Survey 7. MatNeo Service User Feedback (Appendix 6 CQC Maternity Survey Improvement plan/Birth trauma enquiry response) 8. MNVP Update 9. Trust Claims Scorecard 10. Midwifery Staffing Report 11. Maternity Safety Champions & Quad Team Update 12. NHSR (Maternity Incentive Scheme Year 6) NB 2, 6, 7, 8, 9 & 10 are reportable as per NHSR Year 6 NB Appendices 1-6 available in iBabs Documents. Response to the issue: 1. Perinatal Quality Surveillance – Maternity Neonatal Dashboard (Appendix 1) The Maternity & Neonatal Dashboard provides a perinatal quality surveillance overview of indicators for our services. The dashboard outcomes continue to be scrutinised by the Quality and Safety Team and reported to the MatNeo Safety Champions. The following section of the report will provide an update on the key indicators. The remaining red flags on the dashboard are ‘ongoing’, with no new concerns identified. As requirements change additional indictors will be added with recent changes including: • Late fetal losses (16+0-23+6) • Intrapartum stillbirths • PROMPT obstetric emergencies training (work in progress) • Newborn Life Support (NLS) (Data coming) • Maternity Day Assessment Unit (MDAU) Triage times. Page 1 of 9 1.1 % of Bookings by 9+6 weeks (NICE recommendation) Overall compliance for Qtr.1 was  31%. The action plan discussed in the previous report has been extended to continue for 3 months, taking us until the end of July 2024. This remains as a feature (Risk 815 Red 15) on the Risk Register until further notice. NB. As a result of the action and improvement plan mentioned above the number of bookings in May was 633, which is a significant increase from 448 in April. This increase should settle now that the backlog has been cleared. April 5.8% May 30% June 58% 1.2 Timeliness of testing KPI for sickle cell and Thalassemia screening Overall compliance for Qtr.1 was 36%. This surveillance indicator is set against a national benchmark and provides the indicator for the proportion of pregnant women and birthing people having had antenatal sickle cell and thalassemia screening for whom a screening result is available ≤10 weeks + 0 days gestation. This result enables prompt partner testing and the offer of prenatal diagnostic testing if required. The improvements seen in respect to compliance levels in screening have been as a direct result of the changes made to the booking processes. We anticipate further improvements to the screening data as service changes within the self-referral team become formalised. April 6.4% May 33% June 68% The action plan discussed in the previous report has been extended to continue for 3 months, taking us until the end of July 2024. This remains as a feature (Risk 37 Red 15) on the Risk Register until further notice. To note this indicator is intrinsically linked to the % of Bookings by 9+6 weeks and as this compliance increases so will screening compliance. 1.3 Booked onto Continuity of Carer (CoC) pathway The Maternity Continuity of Care Model (MCoC) is a key model that ensures all families, particularly those most vulnerable, have safer and improved outcomes. The outcomes are as follows: • Total booked onto a CoC pathway Current rate for Qtr.1 is 13%, within the target being > 35%. • Global Majority booked onto a CoC pathway Current rate for Qtr. 1 is 23%, which has increased from 14.7% in March, target being > 51%. This workstream has additional team lead oversight to ensure we are targeting those most at risk. April 24% May 22% June 22% Page 2 of 9 • Total booked who are living in IMD1 area booked onto a CoC pathway Current rate for Qtr. 1 is 65%, these women/birthing people are being identified early to ensure they are booked onto a CoC pathway and close oversight by the senior leadership team and NEST team leads. April 41% May 56.5% June 98% 1.4 Education and Training NHSR Year 6 - Safety Action 8 asks Trusts to evidence compliance of 90% for the 3 ‘in-house’ one day multi-professional training days. The Quality and Safety Team have close oversight working with the education leads to ensure progress is maintained for training and education. The need has been identified early and provision sought for additional training days, due to increased acuity operationally and staff being redeployed to work clinically, with the additional resources we are on track to meet compliance by 30 November 2024. 1.5 Neonatal Life Support (NLS) NHSR Year 6 – Safety Action 8 also asks Trusts for evidence of compliance of 90% for neonatal life support. This is included within PROMPT for Maternity Services but is taught separately within Neonatal Services. Targeted education is planned for Autumn 2024 to ensure compliance will be met by the end of the reporting period (November 2024). The process for providing the annual NLS updates within Neonatal Services is being reviewed to apportion it across the year, which includes having an allocated time within the doctor’s induction and adding to the rolling education rota. 2 Serious Incidents (SI) including Maternity and Newborn Safety Investigations (MNSI) and PMRT cases Appendix 2 provides assurance to the members that the appropriate reporting has taken place for Qtr.1. The report includes all new MNSI cases, of which there were 2, and any PSII cases. Also providing an update on all cases closed within the same timeframe, together with any thematic learning identified. Information will also be included which relates to new and closed perinatal mortality cases even where there are no patient safety care concerns for the service to continue to be transparent. 2.1 Appendix 2 also includes a summary of the Moderate incidents reported in April/May 2024 to date. There were 2 cases closed in Qtr.1 and the learning slides featured within the last report: • MNSI 029127 case closed Trust shared learning slide • MNSI 031668 case closed Trust shared learning slide. 2.2 Appendix 2a highlights the Iodine skin prep case learning slide which has been shared with the Local Maternity and Neonatal System (LMNS), case currently an ongoing PSII. 3 Perinatal Mortality Review Tool Report (PMRT) See Appendix 3 for a summary of Qtr.1 PMRT cases and learning. The MatNeo service can confirm that there is high level oversight of reported and processed cases to ensure reviews and feedback from and to families are captured within appropriate timeframes. Page 3 of 9 Case information is reviewed at a level where the service can look to identify any themes or vulnerable groups. Learning has been identified within the information and is shared with our LMNS. 4 ATAIN Qtr.1 Report For Qtr.1 2024/25, there were a total of 41 unexpected admissions. The process for reviewing term admissions has changed and the reasons for admission have also been amended slightly. However, poor perinatal adaptation continues to be the most common reason for admission. Appendix 4 provides a deep dive into Quarter 1 admissions. 5 Quality and Safety Shared Learning Our service continues to drive quality and ensure that safe care is provided to our families. Appendix 5 provides Committee members with an overview of the key learning from the Trust’s quarterly MNSI review meeting. 6 Perinatal Culture Score Survey The Trust is holding feedback sessions with the workforce, facilitated by Korn Ferry (the Score Survey provider), looking to obtain further narrative to support and inform the Change Team (improvement leads) to ensure meaningful results and a positive improvement. 7 MatNeo Service User Feedback 7.1 Friends & Family Overall, for Qtr.1 the Friends and Family feedback continues to be above Trust target at 32.0% with 89% recommending our service. This feedback is reviewed by the senior team and any thematic concerns are identified and improvements planned. 7.2 CQC Maternity Survey Action Plan Appendix 6 outlines the Maternity Improvement Plan following the 2023 CQC Women’s Experiences of Maternity Care Survey, combined with the themes identified in the recent Birth Trauma Enquiry report. Locally we have reviewed the results and have developed an action plan to address the findings. 8 Maternity & Neonatal Voices Partnership (MNVP) Chair Update The Hampshire and Isle of Wight ICB advertised the MNVP chair role on the 24 May 2024, with the closing date of 7 July 2024, subject to recruitment the Trust hopes to have a chair in place soon to support the MatNeo Service to ensure the patient voice is heard and service user engagement in shaping our MatNeo service. 9 Trust Claims Scorecard Qtr.1 Claims Scorecard will be reviewed by the Safety Champions and targeted interventions aimed at improving patient safety would be developed. This will come to the Quality Committee in August for noting as per NHSR Year 6 reporting requirements. Page 4 of 9 10 Midwifery Staffing Report 10.1 A clear breakdown of BirthRate Plus (BR+) or equivalent calculations to demonstrate how the required establishment has been calculated In line with national drivers for assurance in relation to safe staffing levels within maternity services, UHS Maternity Services currently utilise BirthRate Plus (BR+) as a system and framework for workforce planning and strategic decision making. The last assessment of UHS Maternity Services by BR+ in 2018 suggested an overall clinical establishment based on a midwife V birth ratio of 1:24, calculated against an annual birth rate of 5500 births. At the time, the required total establishment as calculated by BR+ to ensure safe staffing levels equated to 226.55 WTE which was inclusive of support staff contribution. UHS recently commissioned a revised BR+ review in March 2024. Whilst we await our final report, early indicators show our service to be operating in a staffing deficit, which indeed feels accurate on a day-to-day basis. Despite a lower birthrate in 23/24 of around 5000, the growing complexity of maternity calls for more input and midwifery care hours throughout pregnancies across the service, whilst also increasingly requiring wider MDT input. Birthrate Plus data shows that UHS continues to see a higher than average case mix with 77% of people falling within the highest acuity / care requirement categories compared to 68% in 2018. In July 2023, we saw a peak in this activity where 91% of women / birthing people delivered on our labour ward or in theatre. This rate has continued into 2024 with the average only falling to around 88% each month. Our normal birth rate has stabilised with an average of 45% however the rising trend we have seen over the last 12 months in caesarean section births, continues to be high and consistently account for over 40% of all births in our service. 10.2 In line with Midwifery staffing recommendations from Ockenden, Trust Boards must provide evidence of funded establishment being compliant with outcomes of BirthRate+ or equivalent calculations Over the last 3 years, UHS Maternity Services have at times been working with midwife V birth ratios that are more suggestive of 1:27. This has felt uncomfortable but with contingency frameworks in place, the service has remained safe. With a vacancy rate of 22.49 WTE currently for registered staff we are presently operating a 1:29 midwife V birth ratio. This situation is further compounded by short-term sickness, an increased national demand for education and training and a high maternity leave rate of 9%. This inevitably results in a workforce that is significantly overstretched carrying an overall headroom percentage of 31%. We have increased staff support in the clinical environment in addition to pastoral and psychological support to enhance retention of the workforce. We are pleased to say that with this initiative, we have retained 100% of our newly qualified preceptees who started with us in November 2023. UHS Maternity Services has a very detailed, robust escalation and contingency plan which is activated when the service is under pressure to maintain safety and improve maternal and neonatal outcomes. The leadership team, including the Director of Midwifery, commit to a high number of out of hours on calls to support the service when in escalation and when staffing does not match the acuity and activity across the acute clinical areas. Page 5 of 9 Whilst effective in bridging gaps for the most part, this is not a sustainable way of working and it is resulting in burnout across the midwifery leadership team. 10.3 Where Trusts are not compliant with a funded establishment based on BirthRate+ or equivalent calculations, Trust Board minutes must show the agreed plan, including timescale for achieving the appropriate uplift in funded establishment. The plan must include mitigation to cover any shortfalls In support of the BR+ acuity tool, UHS Maternity Services have developed a systematic process for workforce planning in the form of a monthly dashboard. This live data is reflective of total staff unavailability to include vacancy rates, sickness ratios, maternity leave, and study time, all of which is compared alongside the budgeted versus actual staffing establishment overall. The data recorded within the monthly dashboard is lifted directly from maternity Erostering and ESR systems. As such the staffing ratios are recorded in real time and will represent staffing levels in their most accurate form. The monthly dashboard not only records an accurate position for midwifery staffing at the current time but also offers a projected forecast for staff unavailability in the months going forward. This ensures and supports an ongoing process for rolling recruitment, involving both qualified and unqualified staff groups. Utilising the dashboard in this way will see the Maternity Service reduce the current vacancy rate down from a predicted 26.58WTE in October 2024 to fully recruited as per our current funded establishment by 1st February 2025, assuming that we are able to maintain engagement from all our new recruits. With national evidence directly linking reduced midwifery staffing levels and poor maternity and neonatal outcomes for families, recruitment to clinical maternity roles, both registered and unregistered has been supported by the Trust Board and prioritised at recruitment panels. With this support, Maternity Services have continued to recruit to vacant posts and following a successful newly qualified midwife recruitment drive, we are expecting 34WTE B5 midwives to join UHS Maternity Services on our preceptorship programme in November 2024. Recognising the level of support that our new colleagues will need, and to create a balanced skill mix across our workforce, we also have a rolling B6 recruitment process which is returning a steady stream of experienced B6 midwives also joining our service. 10.4 Midwifery red flag reporting – Evidencing compliance that all women / birthing people receive 1:1 midwifery care in active labour and the protected supernumerary status of the labour ward coordinator UHS Maternity Services record our staffing V acuity data every 4 hours across the intrapartum areas using the BR+ tool. Within our staffing template the labour ward coordinator is rostered and protected to maintain a supernumerary status at all times. This standard is achieved and maintained across the entirety of every shift, not just the start which is the reportable required standard. The skillset of this staff group is pertinent to the safe running of the labour ward, our most acute and high risk clinical area. The table below offers assurance to the Trust Board that UHS Maternity Services consistently meet this safety standard with no red flag events recorded for the whole of 2023 and to date in 2024. The labour ward coordinator team recognise the specialist nature of their role and reliably respond to cover unexpected vacant shifts. Across our operational Page 6 of 9 and leadership teams, we have staff who also hold the labour ward coordinator skillset as a dual or previous role which offers extra flexibility and redeployment options at times where a substitute coordinator may be required. At UHS, the labour ward coordinator does not take responsibility for any patients nor do they cover breaks for other members of staff enabling them to have continuous oversight of their clinical environment. Red Flag Report - Labour Ward (scheduled assessments only) Red Flag Red Flag Description 2023 total Jan Feb Mar Apr May Any occasion when 1 midwife is not able to provide continuous RF9 one-to-one care and 0 0000 0 support to a woman during established labour RF10 Labour ward coordinator not supernumerary status 0 0000 0 Red Flag Report - Broadlands (scheduled assessments only) Red Flag Red Flag Description 2023 total Jan Feb Mar Apr May Any occasion when 1 midwife is not able to provide continuous RF9 one-to-one care and 0 00 0 0 0 support to a woman during established labour Another red flag that is closely monitored and reportable to the Trust Board as a measure of good practice is the assurance that all women / birthing people receive 1:1 care in active labour across all birth environments. At UHS Maternity Services we respond quickly and effectively to the fast paced, unpredictable nature of intrapartum care and evoke our maternity escalation plan to source additional midwives for intrapartum care. Currently midwives are redeployed often to meet the needs of the service which can cause uncertainty and frustration for them at times. Morale and job satisfaction levels are low amongst midwives who are continuously called upon for support, however all would agree that safe care is the priority. It is only through this escalation that we continue to provide safe care to the women / birthing people accessing our service in the right place, at the right time and by the right people. If we cannot provide 1:1 care in active labour, UHS Maternity Services will declare the highest level of escalation, OPEL 4, and look to divert incoming people in labour to neighbouring Trusts across the region. Since the start of 2024, UHS Maternity Services have escalated to OPEL 4 on 23 occasions. Across the whole of 2023 OPEL 4 was declared 28 times. This is a significant and stark increase in service pressure that our Maternity Service Page 7 of 9 is experiencing with staffing and acuity accounting for the majority of cases. Whilst we report that we are compliant with providing 1:1 care in active labour and we are safe, we are seeing an increase in other reportable red flags such as delays in induction and being unable to facilitate birthplace choices. 10.5 Maternity Workforce Development – Next Steps/Way Forward Over the last year, an extensive listening exercise has taken place to help inform the future direction and structure of the Maternity Service workforce. To align with current service needs, and with staff wellbeing as a central focus, the Director of Midwifery and Midwifery Senior Leadership Team are reviewing the way the service is delivered with the potential of a workforce restructure. Ensuring that an appropriately skilled practitioner is available to meet service demands in the most responsive and efficient way remains pivotal in the success of this potential project. This will be pertinent to models and pathways of care provision, operating both in and out of the hospital setting, including homebirth and intrapartum services within our low-risk birth centres. Drivers around flexible working, retention and restorative practice will all underpin the direction and future of the way in which we work. In terms of strategic workforce planning, there is currently a significant focus around the issue of supply and demand for maternity staff, particularly registered midwives. Some options for workforce development see alternative training pathways for health care workers who previously may not have benefitted from such openings and include shortened midwifery conversion courses for registered nurses, return to practice midwifery courses, midwifery apprenticeship models and foundation programmes for aspiring maternity support workers. It is anticipated that by broadening the gateway into careers within maternity services, whilst allowing training and education to be both accessible and affordable, a wider audience of prospective candidates will be achieved. In these current times where maternity workforce tensions are so prominent, we recognise that succession planning is of prime importance, and therefore are busy creating new opportunities for staff upskilling and professional development. UHS Maternity Services are committed to investing in their people and as such have dedicated programmes for career development starting at band 2 and progressing to band 9. Our prime focus is to consider new ways in which we can future proof our maternity services going forward, whilst investing wholly in the health and wellbeing of our existing workforce. 11 Maternity & Neonatal Safety Champions & Quad Team Update Safety Champions Gail Byrne (Exec) Tim Peachey (Non-Exec) Victoria Puddy (Neonatal) Jillian Connor (Obstetric) Marie Cann (Midwifery) QUAD Bala Thyagarajan (Care Group Clinical Lead) Ganga Verma (Obstetric Clinical Lead) Hannah Kedzia (Care Group Manager) Marie Cann (Midwifery) The Safety Champions and Quad met on the 1 May 2024 for a joint meeting and safety walkabout of the service. There were no additional concerns or actions identified, just the ongoing challenges around staffing and estates recognised. Page 8 of 9 12 NHSR – Maternity Incentive Scheme year 6 The last Quality Committee report provided an exception report for the 10 safety actions. The Trust met with the LMNS on the 27 June 2024 for the first quarterly review meeting, to assess progress against the 10 safety actions, and the trajectory for complete submission is on track. The next review meeting is planned for August, to review progress, ahead of end of the reporting period on the 30 November 2024. Implications: (Clinical, Organisational, Governance, Legal?) The risk implications for the UHS Trust and MatNeo services sit within several frameworks including: • Reputational – Safety concerns can be raised by the public to both NHS Resolution and the CQC. • Financial – Compliance with NHS Resolution Maternity Safety Actions to meet all ten safety actions remains to be an expectation for maternity safety requirements. • Governance – Safety concerns can be escalated to the Care Quality Commission for their consideration and to NHS England, the NHS Improvement Regional Director, the Deputy Chief Midwifery Officer, the Regional Chief Midwife. • Safety - Non-compliance with requirements or recommendations would have a detrimental impact on the women and their families leading to increased poor outcomes and staff wellbeing. MNSI can raise concerns regarding the safety of MatNeo services and instigate reviews. Risks: (Top 3) of Top Risks: carrying out the • 788 (Red) Elective theatre capacity change / or not: • 258 (Red) Maternity staffing • 259 (Red) Capacity and demand in Maternity services • 260 (Red) MDAU • 262 (Red) Induction of Labour Summary: This Qtr.1 MatNeo services safety report provides an overview of the key safety Conclusion workstreams and aims to provide committee members with the actions and and/or mitigations in place to improve areas of significant concern. The report recommendation: encompasses the perinatal quality surveillance minimum requirements and aims to fulfil the reporting requirements for NHSR MIS year 6. The report will continue to be adapted and responsive to safety concerns or issues within our service providing assurance around safety improvements impacting our families, services and staff. The MatNeo dashboard provides the board with the Perinatal Quality Surveillance information and will continue to be refined to provide a platform for clear oversight of key outcomes and measures. We continue to work on ways to ensure the dashboard clearly highlights any action and improvement plans where areas of risk have been identified. The information provided is for assurance and reassurance, whilst meeting the requirements of NHSR Year 6, and highlights the safety improvement work and learning from all aspects of the services including serious incident and MNSI cases. We ask members to continue to support the MatNeo Services and provide monitoring and scrutiny as required. Page 9 of 9 Report to the Trust Board of Directors Title: Agenda item: Sponsor: Date: Purpose: Issue to be addressed: Response to the issue: Chief Executive Officer’s Report 5.5 David French, Chief Executive Officer 25 July 2024 Assurance Approval or reassurance Ratification Information X My report this month covers updates on the following items: • General Election • COVID-19 Inquiry • Forgotten Generation • Ligature Risk • Care Quality Commission • Haemophilia Treatment • LIMS system The response to each of these issues is covered in the report. Implications: Any implications of these issues are covered in the report. (Clinical, Organisational, Governance, Legal?) Summary: Conclusion The Board is asked to note the report. and/or recommendation Page 1 of 5 General Election On 4 July 2024, the UK’s general election result was a clear mandate for the Labour party, returning 412 Members of Parliament which represents a 174-seat majority. Labour’s manifesto commitments in terms of health included: • Using spare capacity in the independent sector to ensure that patients are diagnosed and treated more quickly. • Reform of the NHS to ensure that mental health is given the same attention and focus as physical health. • Modernising the Mental Health Act to address treatment of people with autism and learning difficulties, and racial inequalities perpetuated by the Act. • Implement professional standards and regulate NHS managers. • Set an explicit target to close the black and Asian mortality gap. • Implement the expert recommendations of the Cass Review, the independent review of gender identity services. • Ensure the publication of regular, independent workforce planning across he
Url: /Media/UHS-website-2019/Docs/About-the-Trust/Trust-governance-and-corporate-docs/2024-Trust-documents/Papers-Trust-Board-25-July-2024.pdf

Lead for Imaging Research JD

Description: UHS Lead for Imaging Research Job Role Version v2 28/02/2022 Job Title: Responsible to: Liaises with: Lead for Imaging Research Divisional Clinical Director and Clinical Director of R&D Divisional Senior Management Teams Care Group Managers and Clinical Leads Radiology and Medical Physics senior management teams and staff Director of R&D R&D Manager R&D Head of Nursing and AHPs R&D Divisional Research Management Team CRN Divisional and Speciality Groups Leads Researchers and research teams Tenure: Sessions: 2 years renewable for further 2 years 1-2 PA (dependent on postholder and funding envelope) Job Summary: Strategic Leadership • Work with senior stakeholders to set out the vision for Imaging Research at Southampton, meeting the current and assessing the future demands of researchers and clinical teams • Lead the Southampton Imaging and Radiology Research Group – linking imaging interested researchers across UHS and UoS to develop this group • Drive the development of a long-term, coherent strategy across UHS and UoS to deliver that vision – link this to UHS and UoS strategies • Work with managers to ensure the viability of the strategy, including ongoing workforce development across professional groups and identification of funding opportunities • Be supported by the Radiology and Medical Physics imaging research teams and UHS R&D • Represent imaging research within UHS (for example at monthly R&D steering group meetings) and in any other relevant forums across Southampton and regionally • Engage with the Wessex Imaging Network and SE Imaging Academies to embed research and innovation into the work of these new groups Operational Leadership • Identify the skills and resources required to deliver the agreed strategy and work with managers to fill gaps • Ensure that the imaging research infrastructure in Southampton is resilient and sustainable, to deliver high quality imaging research activity • Work towards costings and funding transparency, and relate this to imaging research activity • Empower all imaging staff to be involved in research at every level • Provide operational oversight and guidance to develop and enable imaging research delivery • Work with CRN Wessex to improve imaging research delivery Academic and Commercial Leadership • Encourage UHS imaging focussed research, especially projects led from within Radiology and Medical Physics at UHS – increase income in relation to this research • Work with SoAR and departmental managers to actively promote research activity across AHP (including radiographers) and healthcare/clinical scientist teams • Work with university leads to identify complementary strengths at UoS and shape an imaging research strategy based on these • Highlight and determine the potential growth of imaging research activity across UHS and UoS (including AI and data science applications) and ensure appropriate priority for this is established in the strategic planning within both organisations 1 • Leverage the commercial value of the UK’s largest Radiology Managed Equipment Services at Southampton (currently provided by Siemens MES) and agree a mutually beneficial research agreement • Collaborate and liaise with other external entities (academic and commercial) to accelerate the development of imaging research in Southampton, to encourage investment and increase income Communication and Profile • Create a well-structured, coherent and dynamic web presence for imaging research in Southampton • Develop multi-disciplinary networks to facilitate discussions between clinical and academic (FoM and wider UoS) teams • Ensure research imaging capability and potential is visible to other key strategic health research areas • Highlight relevant funding opportunities to researchers and collaborators • Establish mechanisms to ensure stakeholders – including our patients and staff – are kept updated about the clinical translation of imaging research outputs and research successes • Ensure our patients are involved in our imaging research at every stage and increase opportunities for them to participate and benefit from imaging research • Publicise imaging research achievements, both internally and externally, through a variety of routes/media. Produce reports and present data at relevant meetings to demonstrate activity • Communicate matters relating to imaging research across divisions and to Trust Management Deliverables: Overarching strategic development: • Address national challenges – aligning with the NIHR Imaging Group • Strategic planning and clear objectives to direct resource, focus activity and enable growth, with a coherent strategy across Radiology & Medical Physics • Profile and visibility – recognition and better integration within UHS and UoS wider research teams Operational delivery and financial gains: • Costing and funding transparency • Income generation and growth • Operational leadership to ensure robust and resilient delivery • Improved data gathering and data management (including for AI) • Improved integration and communication (including across UHS/UoS) through a single pathway Workforce: • An empowered team, enthused by research • Succession planning and contingency capacity • Workforce development and recruitment (both for research and routine clinical work) – multidisciplinary, operational and academic • Academic framework and expertise – increasing imaging-led research and research leaders Research translation and innovation: • Translation and innovation to meet clinical needs • Removal of barriers between UoS and UHS (particularly with Engineering and Electronics and Computer Science) • Commercial confidence – to encourage investment • Regional engagement – an exemplar model for the planned Wessex Imaging Research Collaborative (WIRC) • Efficiencies and clearer pathways – to both delivery and impact 2 Year 1 and 2 objectives • Embed research into the work of ‘imagers’ across UHS – across professions, modalities and departments (Radiology and Medical Physics) by establishing SIRRG, raising the profile of this group via a website and seminars and by appointing research champions within departments/modalities and across professions and sub-specialities • Establish robust research radiographer staffing and succession planning for existing research radiographers in CT and MRI (Alex Blades and Chris Everitt) • Develop accurate costing, activity tracking and income checking procedures for all types of research studies involving imaging – commercial, non-commercial and university/academic • Increase UHS-led imaging research (3-5 new grant funded projects/collaborations/fellowships) • Ensure imaging research data is available for researchers (via XNAT or PACS) and that a fair pricing structure for accessing this data is established. Create workflows and associated documentation for users • Develop an imaging research strategy to align with and support the UHS research strategy and UoS strategies (FoM and others) • Establish the Wessex Imaging Research Collaborative to increase research capacity and improve delivery across Wessex, linking in with the new Wessex Imaging Network 3
Url: /Media/Southampton-Clinical-Research/Downloads/Lead-for-Imaging-Research-JD.pdf

Lead for Imaging Research role JD

Description: UHS Lead for Imaging Research Job Role Version v2 28/02/2022 Job Title: Responsible to: Liaises with: Lead for Imaging Research Divisional Clinical Director and Clinical Director of R&D Divisional Senior Management Teams Care Group Managers and Clinical Leads Radiology and Medical Physics senior management teams and staff Director of R&D R&D Manager R&D Head of Nursing and AHPs R&D Divisional Research Management Team CRN Divisional and Speciality Groups Leads Researchers and research teams Tenure: Sessions: 2 years renewable for further 2 years 1-2 PA (dependent on postholder and funding envelope) Job Summary: Strategic Leadership • Work with senior stakeholders to set out the vision for Imaging Research at Southampton, meeting the current and assessing the future demands of researchers and clinical teams • Lead the Southampton Imaging and Radiology Research Group – linking imaging interested researchers across UHS and UoS to develop this group • Drive the development of a long-term, coherent strategy across UHS and UoS to deliver that vision – link this to UHS and UoS strategies • Work with managers to ensure the viability of the strategy, including ongoing workforce development across professional groups and identification of funding opportunities • Be supported by the Radiology and Medical Physics imaging research teams and UHS R&D • Represent imaging research within UHS (for example at monthly R&D steering group meetings) and in any other relevant forums across Southampton and regionally • Engage with the Wessex Imaging Network and SE Imaging Academies to embed research and innovation into the work of these new groups Operational Leadership • Identify the skills and resources required to deliver the agreed strategy and work with managers to fill gaps • Ensure that the imaging research infrastructure in Southampton is resilient and sustainable, to deliver high quality imaging research activity • Work towards costings and funding transparency, and relate this to imaging research activity • Empower all imaging staff to be involved in research at every level • Provide operational oversight and guidance to develop and enable imaging research delivery • Work with CRN Wessex to improve imaging research delivery Academic and Commercial Leadership • Encourage UHS imaging focussed research, especially projects led from within Radiology and Medical Physics at UHS – increase income in relation to this research • Work with SoAR and departmental managers to actively promote research activity across AHP (including radiographers) and healthcare/clinical scientist teams • Work with university leads to identify complementary strengths at UoS and shape an imaging research strategy based on these • Highlight and determine the potential growth of imaging research activity across UHS and UoS (including AI and data science applications) and ensure appropriate priority for this is established in the strategic planning within both organisations 1 • Leverage the commercial value of the UK’s largest Radiology Managed Equipment Services at Southampton (currently provided by Siemens MES) and agree a mutually beneficial research agreement • Collaborate and liaise with other external entities (academic and commercial) to accelerate the development of imaging research in Southampton, to encourage investment and increase income Communication and Profile • Create a well-structured, coherent and dynamic web presence for imaging research in Southampton • Develop multi-disciplinary networks to facilitate discussions between clinical and academic (FoM and wider UoS) teams • Ensure research imaging capability and potential is visible to other key strategic health research areas • Highlight relevant funding opportunities to researchers and collaborators • Establish mechanisms to ensure stakeholders – including our patients and staff – are kept updated about the clinical translation of imaging research outputs and research successes • Ensure our patients are involved in our imaging research at every stage and increase opportunities for them to participate and benefit from imaging research • Publicise imaging research achievements, both internally and externally, through a variety of routes/media. Produce reports and present data at relevant meetings to demonstrate activity • Communicate matters relating to imaging research across divisions and to Trust Management Deliverables: Overarching strategic development: • Address national challenges – aligning with the NIHR Imaging Group • Strategic planning and clear objectives to direct resource, focus activity and enable growth, with a coherent strategy across Radiology & Medical Physics • Profile and visibility – recognition and better integration within UHS and UoS wider research teams Operational delivery and financial gains: • Costing and funding transparency • Income generation and growth • Operational leadership to ensure robust and resilient delivery • Improved data gathering and data management (including for AI) • Improved integration and communication (including across UHS/UoS) through a single pathway Workforce: • An empowered team, enthused by research • Succession planning and contingency capacity • Workforce development and recruitment (both for research and routine clinical work) – multidisciplinary, operational and academic • Academic framework and expertise – increasing imaging-led research and research leaders Research translation and innovation: • Translation and innovation to meet clinical needs • Removal of barriers between UoS and UHS (particularly with Engineering and Electronics and Computer Science) • Commercial confidence – to encourage investment • Regional engagement – an exemplar model for the planned Wessex Imaging Research Collaborative (WIRC) • Efficiencies and clearer pathways – to both delivery and impact 2 Year 1 and 2 objectives • Embed research into the work of ‘imagers’ across UHS – across professions, modalities and departments (Radiology and Medical Physics) by establishing SIRRG, raising the profile of this group via a website and seminars and by appointing research champions within departments/modalities and across professions and sub-specialities • Establish robust research radiographer staffing and succession planning for existing research radiographers in CT and MRI (Alex Blades and Chris Everitt) • Develop accurate costing, activity tracking and income checking procedures for all types of research studies involving imaging – commercial, non-commercial and university/academic • Increase UHS-led imaging research (3-5 new grant funded projects/collaborations/fellowships) • Ensure imaging research data is available for researchers (via XNAT or PACS) and that a fair pricing structure for accessing this data is established. Create workflows and associated documentation for users • Develop an imaging research strategy to align with and support the UHS research strategy and UoS strategies (FoM and others) • Establish the Wessex Imaging Research Collaborative to increase research capacity and improve delivery across Wessex, linking in with the new Wessex Imaging Network 3
Url: /Media/Southampton-Clinical-Research/Downloads/Lead-for-Imaging-Research-role-JD.pdf

ACCORD-2 example sub-protocol

Description: CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TITLE PAGE Master Protocol Title: ACCORD-2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients Sub-protocol Number: ACCORD-2-002 Sub-protocol for Candidate Agent: Bemcentinib Study Phase: 2 Sponsor Name: University Hospital Southampton NHS Foundation Trust Legal Registered Address: Southampton General Hospital Level E, Laboratory & Pathology Block, SCBR - MP138 Tremona Road Southampton SO16 6YD, UK Regulatory Agency Identifying Number(s): EudraCT: 2020-001736-95 IRAS Number: 282769 RHM Number: Date of Sub-protocol: 22 April 2020 Version: Protocol Amendment 01 Caution: In accordance with cardiac exclusion criteria, in particular Exclusion 13, drugs known to cause QT prolongation should be discontinued/replaced, with sufficient time (5 half-lives) for washout. Patients in these categories of potential risk should be discussed directly by telephone with BerGenBio: Prof Hani Gabra, BerGenBio Chief Medical Officer: +44 7810 576112 Dr Akil Jackson, BerGenBio Medical Director: +44 7810 575037 Final, 22 April 2020 1 CONFIDENTIAL Sponsor Signatory: ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Professor Tom Wilkinson MA Cantab MBBS PhD FRCP Professor of Respiratory Medicine and Honorary NHS Consultant Physician 22/04/2020 Date Final, 22 April 2020 2 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) TABLE OF CONTENTS TABLE OF FIGURES.............................................................................................................4 PROTOCOL AMENDMENT HISTORY .............................................................................5 1.0 SUB-PROTOCOL SUMMARY .................................................................................6 1.1 Overview of Sub-protocol................................................................................6 1.2 Schedule of Activities .......................................................................................8 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 .........................................................................................................12 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro..........................13 2.2 Dose Justification for Bemcentinib...............................................................14 2.3 Human Experience from Trials in Cancer Patients ...................................16 3.0 STUDY POPULATION ............................................................................................18 3.1 Eligibility Criteria ..........................................................................................18 4.0 STUDY ASSESSMENTS AND PROCEDURES ....................................................19 4.1 Efficacy Assessments .....................................................................................19 4.2 Safety Assessments.........................................................................................19 4.2.1 Adverse Events ..................................................................................20 4.2.2 Clinical Safety Laboratory Assessments ...........................................20 4.3 Pharmacokinetic Assessments ......................................................................20 4.4 Pharmacodynamic Assessments ...................................................................20 5.0 STUDY TREATMENT .............................................................................................21 5.1 Conclusions and Risk Benefit Statement .....................................................21 5.2 Bemcentinib Drug Administration ...............................................................21 5.3 Dose Modifications and Toxicity Management ...........................................22 5.4 Prohibited Concomitant Medications ..........................................................22 5.5 Study Drug Information................................................................................22 5.5.1 Study Medication...............................................................................22 5.5.2 Bemcentinib Storage, Dispensing, and Destruction ..........................23 6.0 REFERENCES...........................................................................................................24 7.0 APPENDICES ............................................................................................................26 Appendix 1 Abbreviations ...................................................................................26 Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index ..........................................................................................27 Final, 22 April 2020 3 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator ................................................................28 Figure 1 Figure 2 Figure 3 TABLE OF FIGURES Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells .............................14 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) .....................................................15 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients .............................................................................................................16 Final, 22 April 2020 4 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) PROTOCOL AMENDMENT HISTORY Protocol amendment 01 (dated 22 April 2020) replaces the original sub-protocol for bemcentinib (dated 20 April 2020). The amendment incorporates the following main changes: • A change of Sponsor, from BerGenBio ASA to University Hospital Southampton NHS Foundation Trust, with a corresponding change to the named Sponsor signatory. • Addition of exclusion criterion for clinically significant hypokalaemia. • Clarification that for the exclusion criterion of inability to swallow capsules, administration via nasogastric tube is permitted. • Clarification that the physical examination at screening includes height and weight (this is part of the Master Protocol). • Addition of samples for cytokine analysis and PBMC phenotyping on the Schedule of Activities (this is part of the Master Protocol). • Removal of specific blood volumes from the Schedule of Activities. • Clarified that analysis of inflammatory cytokines is part of the Master Protocol. • Clarification regarding known adverse events for bemcentinib. Final, 22 April 2020 5 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.0 SUB-PROTOCOL SUMMARY 1.1 Overview of Sub-protocol Bemcentinib is a small molecule AXL kinase inhibitor developed by BerGenBio ASA (the candidate agent owner) which has demonstrated potent and selective inhibition of AXL in biochemical and cell-based kinase inhibition assays. AXL is a recognised therapeutic target for the treatment of cancer. AXL regulates cancer cell survival and immunosuppressive modulatory effects, particularly in driving immunosuppressive features of the innate immune compartment in the tumour microenvironment, including activation of the myeloid derived suppressor cells, the M2 macrophage state, and suppressor regulatory dendritic cells that inhibit activated T cell function. Further, AXL is an important negative regulator of type I interferon (IFN) responses that are important for anti-cancer treatments. Bemcentinib is currently being developed for the treatment of cancer, particularly in non-small cell lung carcinoma, acute myeloid leukaemia (AML), myelodysplastic syndrome, and other cancers. The AXL receptor mediates entry of enveloped viruses such as Zika and Ebola through “apoptotic mimicry”. Phosphatidylserine (PS) on the viral envelope is tethered to AXL by its bound ligand, growth arrest-specific 6 (GAS6), leading to viral internalisation. Viruses also activate AXL signal transduction that antagonises anti-viral type-I IFN responses. Preclinical data show that AXL-mediated internalization and IFN suppression may extend to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and that bemcentinib can inhibit coronavirus entry and replication. The hypothesis is therefore that bemcentinib is a potentially effective treatment for COVID-19 disease. Additionally the Sponsor’s understanding of the mechanism supports testing the hypothesis that bemcentinib may be an effective preventive/prophylactic therapy for COVID-19. This sub-protocol describes the approach for study conduct of the bemcentinib arm within the ACCORD-2 multicentre, Phase 2 adaptive randomisation platform study to assess the efficacy and safety of multiple candidate agents for the treatment of COVID-19 in hospitalised patients. Key differentiating features of this sub-protocol include the following: (a) Bemcentinib is an oral 100-mg capsule, recommended Phase 2 dose (RP2D) is 200 mg given once daily, following a loading dose (400 mg) given once daily for 3 days. Although the Master Protocol plans for 15 days of treatment, this sub-protocol can provide up to 21 days of bemcentinib treatment if required for patients. (b) A specific eligibility criterion has been added to exclude patients based on electrocardiogram (ECG) QT interval on screening above 450 msec (a lower exclusion limit than that stated in the Master Protocol, 500 msec), as well as significant cardiac comorbidity. Any concomitant medication with QT prolongation risk must be stopped at screening and direct discussion between the investigator and Sponsor Medical Monitors will allow support in risk management. Serial ECG measurements have been added in Final, 22 April 2020 6 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) order to pragmatically monitor any QT interval change with bemcentinib, coupled to a sparse pharmacokinetic (PK) sample schedule, in the hospitalised COVID-19 population. Within the clinical development programme to date, over 286 patients have been treated without any observed cardiac adverse events (AEs). (c) Translational and pharmacodynamic (PD) sampling is included in this protocol. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. (d) Selected secondary endpoints from the Master Protocol will be considered as key secondary endpoints for the purposes of this sub-protocol. Final, 22 April 2020 7 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 1.2 Schedule of Activities Screening Baseline Day (± Window) ELIGIBILITY Informed consent Demographics Relevant medical historyb Review SARS-CoV-2 diagnostic tests Inclusion and exclusion criteria STUDY INTERVENTION Randomisation Administration of bemcentinibc Treatment with SoC STUDY PROCEDURES Clinical frailty score Diagnostic imaging (X-ray and/or computed tomography) Physical examination (including presenting symptoms, height, weight) Targeted physical examination (focused on lung auscultation) Day -1 or Day 1 Day 1 X X X X X X Days 1-3 400 mg loading daily X X X X Daily Until Hospital Discharge X 200 mg maintenance X X Day 15a (±2 days) X Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Final, 22 April 2020 8 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Vital signs, including oral temperature, pulse rate, blood pressure, respiratory rate, SpO2 Clinical assessmentse Targeted medication review (including use of vasopressors) Adverse event evaluation Disease-related co-infection evaluation (including microbiologic/infectious agent assessment/results; bacteria, viral, fungi) Survival status Blood gases and FiO2 at worst PO2f 12-lead ECGg SAFETY LABORATORY Haematology, chemistry, liver function tests, coagulationh Pregnancy test for females of childbearing potential RESEARCH LABORATORY Blood (SST) for exploratory inflammatory cytokine analysis Blood (sodium heparin tube) for PBMC phenotypingl Day -1 or Day 1 X X Xi Xi Day 1 Xd Xd Xd X X X X X Xd,j X X Daily Until Hospital Discharge X X X X X X X See schedule belowg Days 3, 5, 8, 11 (all ±1 day) if hospitalised Day 8 Day 8 Day 15a (±2 days) X X X X X X Xk X X Day 29a (±3 days) X X X X X Xk X X Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) X X X X Final, 22 April 2020 9 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Screening Baseline Day (± Window) Day -1 or Day 1 Day 1 Daily Until Hospital Discharge Day 15a (±2 days) Day 29a (±3 days) Day 60a Day 90a (±4 days) (±6 days) (Follow-up) (End of Study) Blood (EDTA) for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Oropharyngeal/nasal swab for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Saliva for SARS-CoV-2 PCR (qualitative and quantitative) X Days 3, 5, 8, 11 (all ±1 day) if hospitalised X X Blood (SST) for SARS-CoV-2 serology research (host response) X Day 8 X X X Blood (PAXGENE) for transcriptome analysis (host genome)m X Day 8 X Blood (EDTA) host genome (host DNA)m X Mid-turbinate nasal swab viral genomem X Blood samples for PD and translational studiesn X See schedule belown X X X PK samplingn X See schedule belown X ECG=electrocardiogram; EDTA=ethylenediaminetetraacetic acid; FiO2=fraction of inspired oxygen; PBMC=peripheral blood mononuclear cell; PCR=polymerase chain reaction; PD=pharmacodynamic; PK=pharmacokinetic; PO2=partial pressure of oxygen; RT PCR=reverse transcription polymerase chain reaction; SARS-CoV-2= severe acute respiratory syndrome coronavirus 2; SoC=standard of care; SpO2=oxygen saturation; SST=serum separator tube. a These visits will be performed even if a patient has already been discharged. If discharged prior to scheduled visit, in-person visits are preferred, but recognising that quarantine and other factors may limit the patient’s ability to return to the clinic, these visits may be conducted by telephone or with a home visit by study staff. For visits conducted by telephone, it will not be possible to perform some scheduled assessments (eg, vital signs). The Day 29 assessments will also be performed, where possible, for patients who discontinue the study prematurely. b Medical history includes estimated date and time of first symptoms and number of co-morbidities (eg, respiratory, cardiovascular, metabolic, malignancy, endocrine, gastrointestinal, immunologic, renal). Final, 22 April 2020 10 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) c Although the Master Protocol plans for 15 days treatment, this sub protocol can provide up to 21 days bemcentinib treatment if required for patients. Bemcentinib should be taken once per day, in the morning, on an empty stomach with water. Patients should not consume anything other than water for at least 1 hour after taking study drug. d Baseline assessments should be performed prior to study drug administration. e Includes ordinal score, National Early Warning Score 2 (NEWS2), oxygen requirement, noninvasive or invasive ventilator requirement, including start and stop of low- or high-flow oxygen supply or of any form of ventilation etc. f If done as part of SoC, blood gases results to be fully recorded with date and time. g ECG to coincide with selected PK and PD sampling timepoints, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. h For parameters, see Master Protocol i Laboratory tests performed in the 48 hours prior to enrolment will be accepted for determination of eligibility. j Any laboratory tests performed as part of routine clinical care within the specified visit window can be used for safety laboratory testing. k Additional safety laboratory evaluations to be performed on Days 15 and 29 only if patient is still hospitalised. l Samples collected for immediate laboratory processing and frozen storage. m Samples collected dependent on capacity of study centre, need for reduced study burden on staff, and potentially limited access to patients. n Procedures for the collection, processing, storage and shipment of the PK and PD samples will be provided in the Study Laboratory Manual. Sample collection to coincide with the ECGs, ie, pre-loading dose (Day 1); then pre-maintenance dose and 6 hours postdose (Day 4). Subsequently predose on Days 8 and 15. Final, 22 April 2020 11 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 2.0 BACKGROUND/RATIONALE IN SUPPORT OF BEMCENTINIB FOR COVID-19 Nonclinical in vitro and in vivo data suggest that bemcentinib might be useful for the treatment of early SARS-CoV-2 infection for which no medical countermeasures are currently approved, and support testing the efficacy of bemcentinib treatment among hospitalised adults with COVID-19. The AXL receptor tyrosine kinase promotes the infection of a wide range of enveloped viruses including pox-, retro-, flavi-, arena-, filo-, and alpha-viruses (Shimojima 2006, Brindley 2011, Meertens 2012, Dowall 2016, Meertens 2017). AXL increases viral infection through two mechanisms: 1) enhanced viral entry through “apoptotic mimicry”; and 2) suppression of anti-viral type I IFN responses. The AXL receptor and related receptors (Tyro3 and MerTK, collectively TAM) are important for the clearance of apoptotic cells (efferocytosis) by macrophages (Lemke 2019). Enveloped viruses co-opt this mechanism to expand tropism and enhance viral entry. GAS6, the AXL ligand, binds PS exposed on the surface of the viral envelope, tethering the viral particle to the AXL receptor and promoting uptake by phagocytosis. This mechanism of viral entry, based on PS exposure, is common to most enveloped viruses and is termed viral “apoptotic mimicry” (Mercer 2008, Bhattacharyya 2013). Binding of the viral particle to GAS6-AXL potently activates signal transduction through its tyrosine kinase domain to suppress type I IFN signalling and facilitate viral replication (Bhattacharyya 2013, Meertens 2017). AXL expression is induced by inflammation and serves as an innate immune checkpoint. AXL signalling suppresses viral-induced IFN responses via suppressor of cytokine signalling (SOCS)1/3, leading to increased viral replication in infected cells and decreased anti-viral defences of neighbouring cells (Huang 2015, Chen 2018, Strange 2019). Consequently, Axl-null mice are resistant to Zika pathogenesis likely due to a combination of reduced virus entry and enhanced IFN responses (Hastings 2019), indicating a potential role for AXL inhibitors as therapeutics during viral infection. Therapeutic AXL receptor inhibition ameliorated pulmonary pathology resulting from primary viral infection in experimental models, indicating an important role for AXL within the lung (Shibata 2014). During primary respiratory syncytial virus (RSV) infection, AXL inhibition increased the number of IFNg–producing T cells and natural killer (NK) cells, suppressed RSV replication and whole lung levels of interleukin (IL)-4 and IL-13. Also, the lethal effect of intrapulmonary H1N1 infection inflammation was reduced by AXL inhibition. AXL inhibition in infected mice increased the number of IFN-b–producing macrophages and dendritic cells and suppressed neutrophil infiltration. Final, 22 April 2020 12 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Bemcentinib is a clinical-stage, oral, selective small molecule AXL kinase inhibitor with well documented anti-viral effects in several systems. Bemcentinib is reported to block dengue, Ebola and Zika virus infections in several cell types including epithelial, fibroblast, endothelial, neuronal and myeloid cell types in in vitro cell culture and organoid systems. Bemcentinib treatment is associated with increased IFN signalling and reduced viral replication (Dowall 2016, Meertens 2017, Strange 2019). During the 2013/2014 Ebola virus (EBOV) outbreak, bemcentinib was 1 of 60 compounds evaluated by Public Health England as an experimental therapy for EBOV, using its Biosafety Containment Level 4 facilities at Porton Down. Bemcentinib 200 mg/kg/day starting 6 hours post viral challenge protected 1/6 EBOV infected guinea pigs from weight loss and early mortality in an 18-day in vivo mortality study (Dowall 2016), compared with 1/6 untreated animals surviving to Day 18 but exhibiting weight loss during the observation period. The authors concluded that bemcentinib may have had some protective effect in this model. 2.1 Preliminary Efficacy Data vs with SARS-CoV-2 In vitro Professor Wendy Maury, University of Iowa, conducted a preliminary analysis of the anti-viral effects of bemcentinib on SARS-CoV-2 in a Vero E6 cell line. As shown in Figure 1, bemcentinib incubation starting 1 hour prior to virus inoculation potently inhibited SARS-CoV-2 infection of Vero E6 cells in a dose-dependent manner. Other studies using vesicular stomatitis virus pseudotyped with SARS-CoV spike protein and a mouse betacoronavirus (mouse hepatitis virus [MHV]) showed that bemcentinib may both inhibit uptake and activate the IFN-mediated antiviral gene, ISG15, to control viral infection. SARS-CoV-2 cell tropism is likely to include PS dependent viral uptake and may target critical immune cell populations (eg, macrophages, dendritic cells) that produce IFN and mobilize anti-viral immunity. Importantly, delayed IFN signalling is characteristic of pathogenic human betacoronaviruses and correlates with disease severity in animal models, suggesting that early intervention with IFN-activating treatment may provide therapeutic benefit (Channappanavar 2016). Thus, AXL targeting is expected to attenuate SARS-CoV-2 pathogenesis both by limiting viral uptake and promoting innate antiviral immunity. Final, 22 April 2020 13 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 1 Bemcentinib Potently Inhibits Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection of Vero E6 Cells Vero E6 cells (60,000) in a 48-well format were incubated (1 hour) with bemcentinib prior to addition of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (MOI 0.0005). Cells were lysed at 24 hours and viral load was analysed by quantitative reverse transcription polymerase chain reaction (RT-PCR) for spike protein gene expression as normalized to the housekeeping gene Cyclophilin. W.Maury et al., unpublished results Importantly, recent data that differentiate SARS-CoV-2 from severe acute respiratory syndrome (SARS) have emerged that support the hypothesis that AXL may have a more dominant role in SARS-CoV-2 infection, and therefore that bemcentinib may have specifically a more important role to play in inhibiting this viral infection: • SARS-CoV-2 has similar replication kinetics to SARS-CoV, but demonstrates differential sensitivity to type I interferon treatment (One of 2 mechanisms of action of Bemcentinib through AXL inhibition) (Lokugamage 2020). • Structural analysis of the spike (S) protein of SARS-CoV-2 showed that its S protein has weaker binding to the angiotensin converting enzyme (ACE)2 receptor on human cells compared with strong affinity of human SARS coronavirus (Dong 2020) – supporting the large magnitude effect we have observed for inhibition of viral replication using clinically appropriate doses of bemcentinib in ACE2 receptor +ve cells. 2.2 Dose Justification for Bemcentinib Bemcentinib’s antiviral action stems from a cellular effect, inhibiting AXL kinase to prevent viral attachment and intracellular viral replication (through maximisation of the early type-I interferon rather than a direct antiviral action). From estimates of pooled data, the half maximal inhibitory concentration (IC50) at 24 hours for bemcentinib inhibition of viral load is approximately 140 nM and the approximate concentration required for 90% of maximum inhibition (IC90) is 650 nM. This broadly corresponds to cancer cell data demonstrating high Final, 22 April 2020 14 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) potency of bemcentinib to inhibit AXL. This high potency is reflected in translational data from clinical trials that demonstrate that at the RP2D steady state, AXL kinase is completely inhibited in myeloblasts from AML patients on bemcentinib (Figure 2). Clinically, at RP2D, AXL kinase target demonstrates complete kinase inhibition (Figure 2), thus the maximal possible antiviral effect with this mechanism of action is accessed at the current clinical dose. Clinically, frequent monotherapy complete responses are observed in AML at RP2D (Figure 2). Bemcentinib PK exhibits a prolonged enteral absorptive phase which overlaps with prolonged elimination kinetics after the second dose, to proportionately reduce peak-to-trough difference in plasma concentration-time profile, over a 24-hour dose interval, resulting in smooth steady state without noticeable peak to trough variation (Figure 3). Thus, at the clinical RP2D it is predicted that bemcentinib would be a highly potent antiviral against SARS-CoV-2, and potentially as efficacious as its main use an anticancer therapeutic. Figure 2 Complete Inhibition of AXL Kinase Activation (p-Axl) in Two Acute Myeloid Leukaemia Patients Treated at the Recommended Phase 2 Dose (200 mg Maintenance Daily Dosing) C=cycle; D=day; Pat=patient Final, 22 April 2020 15 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Figure 3 Bemcentinib Plasma Pharmacokinetics in Acute Myeloid Leukaemia Patients Bemcentinib is given orally as 100-mg capsules. Early clinical development in oncology patients identified the RP2D; dose administration of bemcentinib in this study will utilise the same dosing regimen, ie, a loading dose (400 mg) given once daily for 3 days followed by a maintenance dose of 200 mg once daily. Planned duration of bemcentinib treatment is for a total of 15 days, with the possibility of extension to 21 days for in-patients, at the discretion of the clinical investigator. In preclinical and Phase 1 clinical studies, it was shown that systemic exposure to bemcentinib increased dose proportionately. The terminal half-life was 45.6 to 88.7 hours in man. Modelling of the PK data from this study indicated that the most effective approach to rapidly achieving steady state is to administer 3 daily loading doses followed by a lower daily maintenance dose. 2.3 Human Experience from Trials in Cancer Patients Experience has been gained in the use of bemcentinib in the treatment of many types of cancer (including over 286 patients treated with AML, lung cancer, breast cancer, melanoma, and pancreatic cancer) in Phase 2 clinical studies. This has helped to define the safety profile, recommended dose and schedule as a monotherapy (Loges et al 2018). The safety profile of bemcentinib, initially ascertained in normal human volunteers is tolerable and allows monotherapy approaches as well as combinations with chemotherapy (low dose cytosine arabinoside or with docetaxel), targeted therapy (epidermal growth factor receptor inhibitors) and immunotherapy (pembrolizumab). Bemcentinib is given as two oral capsules once daily (200 mg) following three daily 400 mg loading doses, to achieve steady state. Its principal significant AEs are a low incidence of diarrhoea (28% , with 6% Grade 3/4), asymptomatic QT prolongation (6% Grade 3/4), asthenia, and nausea at the RP2D (Loges et al 2018). Many patients have received bemcentinib without untoward effects for over 2 years at full dose. In particular, there were no QTc related cardiac sequelae observed with either monotherapy or combination therapy in over 286 cancer patients, including elderly multimorbid patients (as presented in the Investigator’s Brochure). Evidence of monotherapy efficacy has been Final, 22 April 2020 16 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) documented in heavily pre-treated patients with AML. Complete response rates of approximately 40% have been observed in AXL expressing AML patients (Loges et al 2018), indicating on-target potency and specificity of bemcentinib as a monotherapy, through complete inhibition of the AXL kinase target. Treatment was well tolerated by most subjects, including the frail elderly. Bemcentinib was well tolerated when combined with pembrolizumab, demonstrating synergy with programmed cell death-1 (PD-1) antagonists through targeting of AXL-dependent immune suppressive mechanisms (M2 macrophages, suppressor dendritic cells, regulatory T cells, and myeloid derived suppressor cells). Collectively, bemcentinib mediated activation of innate immunity within the tumour microenvironment synergizes with immune checkpoint therapy (Krebs et al 2019). Final, 22 April 2020 17 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 3.0 STUDY POPULATION 3.1 Eligibility Criteria Overall inclusion and exclusion criteria are presented in Sections 5.1 and 5.2 of the Master Protocol, respectively. Additional exclusion criteria that are specific to the sub-protocol are as follows: 12. Inability to swallow capsules (administration via nasogastric tube is permitted) 13. Current treatment with any agent known to cause QT prolongation. See Appendix 2 for list of relevant medications. The treatment can be discontinued, with sufficient time (5 half-lives) for washout, to allow inclusion of the patient. 14. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) > 450 ms 15. Clinically significant hypokalaemia. Individuals who do not meet this criterion may be rescreened once. 16. Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included. 17. Previous bowel resection that would interfere with drug absorption Final, 22 April 2020 18 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.0 STUDY ASSESSMENTS AND PROCEDURES In addition to the study assessments and procedures described in Section 8.0 of the Master Protocol, assessments specific to the sub-protocol will be performed as described in the following sections. The Schedule of Activities (SoA) for this sub-protocol is presented in Section 1.2. 4.1 Efficacy Assessments Efficacy assessments will be included as per the Master Protocol. The following endpoints, secondary endpoints in the Master Protocol, will be considered as key secondary endpoints for the purposes of this sub-protocol: Table 1. Bemcentinib Sub-protocol Specific Key Objectives and Endpoints Objectives • To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points • To evaluate the number of oxygen-free days. • To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. • To evaluate SARS-CoV-2 viral load. • To evaluate SARS-CoV-2 viral load. Endpoints • The proportion of patients not deteriorating according to the ordinal scale by 1, 2, or 3 points on Days 2, 8, 15, 22, and 29. • Duration (days) of oxygen use and oxygen-free days. • Duration (days) of ventilation and ventilation-free days. • Incidence of any form of new ventilation use and duration (days) of new ventilation use. • Qualitative and quantitative polymerase chain reaction (PCR) determination of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in oropharyngeal/nasal swab while hospitalised on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 • Qualitative and quantitative PCR determination of SARS-CoV-2 in blood and saliva (while hospitalised) on Days 1, 3, 5, 8, 11, 15, and (optional) Day 29 (may be become a secondary endpoint once the assays are available). Exploratory studies will define the role of PD biomarkers. Exploratory endpoints relate to the translational plan. 4.2 Safety Assessments For ECG assessments see the SoA (Section 1.2). Timing of the PK and PD evaluations will be matched to the ECG assessments. Final, 22 April 2020 19 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 4.2.1 Adverse Events 4.2.1.1 Adverse Events from Indications Under Investigation Bemcentinib is a relatively safe investigational therapeutic agent. A few patients may experience tiredness and gastrointestinal disturbance (nausea, diarrhoea). Occasionally there may be some changes to blood tests relating to liver function (transaminitis) and some changes on ECG tracing (QT prolongation). These AEs are temporary and lasting only a few days. 4.2.1.2 Adverse Events of Special Interest (AESI) Not applicable. 4.2.1.3 Disease-related Events and/or Disease-related Outcomes Not Qualifying as Adverse Events or Serious Adverse Events Not applicable. 4.2.2 Clinical Safety Laboratory Assessments See Master Protocol for the list of clinical laboratory tests to be performed for this sub-protocol, and the SoA (Section 1.2) for the timing and frequency. 4.3 Pharmacokinetic Assessments Venous blood samples for PK analysis will be collected according to the SoA (Section 1.2). The samples will be analysed for plasma bemcentinib and additionally for bemcentinib metabolites (to be defined). Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. Plasma samples for determination of bemcentinib concentration will be analysed by BerGenBio’s Bioanalytical Services vendor using the validated liquid chromatography with tandem mass spectrometry method. 4.4 Pharmacodynamic Assessments Blood samples for PD analysis will be collected according to the SoA (Section 1.2) and stored for future analysis in both the bemcentinib arm and the control arm. The samples will be analysed for soluble AXL, GAS6 (which could be predictive, PD, and mechanism biomarkers and hence require comparison with control group not receiving bemcentinib), and other blood proteins. Detailed procedures for the collection, processing, storage and shipment of the samples will be provided in the Study Laboratory Manual. This analysis will be in addition to the inflammatory cytokine analysis detailed in the Master Protocol. Final, 22 April 2020 20 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.0 STUDY TREATMENT 5.1 Conclusions and Risk Benefit Statement Bemcentinib has shown in vitro evidence of antiviral effect against SARS-CoV-2 infection at concentrations below those achieved at the proposed dose regimen for use in this trial. This dose matches the RP2D derived from multiple studies in various cancer populations. Treatment at this dose in 286 patients over a range of 6 weeks up to 2 years demonstrates that monotherapy or combination is largely well tolerated; therefore short term administration (15 to 21 days) in the context of hospitalized patients with SARS-CoV-2 infection is anticipated to be well tolerated. A non-severe, asymptomatic effect on QTc interval has been noted. Regular ECG/continuous ECG monitoring is included in the clinical trial enabling early identification of prolonged QTc and early stopping rules given the high morbidity and potential mortality of SARS-CoV-2 in hospitalised patients, there is a favourable balance of potential benefit: risk in the proposed clinical investigation of bemcentinib treatment for COVID-19 within the context of this clinical trial. 5.2 Bemcentinib Drug Administration Bemcentinib will be administered as a 400 mg oral loading dose on Days 1, 2, and 3, followed by 200 mg once-daily oral maintenance dose for 15 days with the possibility of extension to 21 days for in patients at the discretion of the clinical investigator. Bemcentinib should be taken once per day, in the morning after an overnight fast. Tablets should be taken with 100 mL water. Patients should not consume anything other than water for at least 1 hour after taking study drug. Final, 22 April 2020 21 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 5.3 Dose Modifications and Toxicity Management Note: this modified guidance has been added to the Investigators’ Brochure under relevant section of treatment of COVID-19 Event Recommended Bemcentinib Dose Modification Estimated creatinine clearance decreases Study medication should be withheld until estimated creatinine by more than ≥50% from baseline clearance returns to baseline ALT or AST increases to > 5 ULN Study medication should be withheld until ALT and AST returns to baseline Dose Modification of Bemcentinib Daily Dose for QTc Prolongation QTcF Recommended Bemcentinib Dose Modification > 501 ms 1st occurrence Discontinue permanently Ventricular arrhythmia 1st occurrence Discontinue permanently ALT=alanine aminotransferase; AST=aspartate aminotransferase; QTcF= QTc interval according to Fridericia correction; ULN=upper limit of normal Notes: Serum calcium, magnesium and potassium should be measured regularly whilst receiving bemcentinib; all abnormal results should be corrected; check for use of concomitant medication that are associated with QT prolongation. 5.4 Prohibited Concomitant Medications Administration of bemcentinib is contraindicated in patients requiring treatment with concomitant medications known to prolong QTc interval and promote Torsade de Points (TdP) listed in Appendix 2. Patients already in receipt of such medications should be excluded unless medications are discontinued and a sufficient wash out period is allowed prior to starting bemcentinib. Medicines with both cytochrome P450 (CYP) 3A4 and TdP liabilities are particularly hazardous and their concomitant use is a reason for exclusion of patients. Concomitant medications that are CYP3A4 substrates are not reasons for exclusion of patients, however they should be discontinued or used with caution. Treatment with histamine receptor 2 inhibitors (cimetidine, ranitidine) or protein pump inhibitors (omeprazole) is permitted provided that administration is in the evening. 5.5 Study Drug Information 5.5.1 Study Medication The drug product is presented in a single strength: 100 mg bemcentinib in size 0, Swedish Orange hydroxypropyl methylcellulose capsules for oral administration. Bemcentinib capsules Final, 22 April 2020 22 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) consists of a wet granulated blend of 40% drug substance with standard excipients (lactose monohydrate, microcrystalline cellulose, crospovidone, polyvinylpyrrolidone, colloidal silicon dioxide, and magnesium stearate). Bemcentinib has been manufactured according to appropriate Good Manufacturing Practice standards. Bemcentinib capsules are packaged in 50-mL white opaque round high density polyethylene bottles containing 22 capsules. The bottles are closed with opaque 32-mm child-resistant screw caps and sealed with tamper-resistant tape. Refer to the current version of the Bemcentinib Investigational Medicinal Product Dossier/Investigator’s Brochure for additional information on the physical, chemical and pharmaceutical properties of bemcentinib. 5.5.2 Bemcentinib Storage, Dispensing, and Destruction Bemcentinib will be shipped to the participating site by PCI Pharma Services, UK, and must be stored at the site in a secure location under ambient temperature conditions (<25°C). Accountability for study treatment is the responsibility of the Investigator. The Investigator/designee must ensure that the bemcentinib will only be dispensed to patients in accordance with the dosing instructions in this protocol. Study staff should refer to the Bemcentinib Pharmacy Manual for specific instructions regarding the handling, storage, dispensing and destruction of bemcentinib. Final, 22 April 2020 23 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 6.0 REFERENCES Bhattacharyya S, Zagórska A, Lew ED, et al. Enveloped viruses disable innate immune responses in dendritic cells by direct activation of TAM receptors. Cell Host Microbe 2013;14:136-47. Brindley MA, Hunt CL, Kondratowicz AS, et al. Tyrosine kinase receptor Axl enhances entry of Zaire ebolavirus without direct interactions with the viral glycoprotein. Virology 2011;415:83-94. Channappanavar R, Fehr AR, Vijay R, et al. Dysregulated Type I Interferon and Inflammatory Monocyte-Macrophage Responses Cause Lethal Pneumonia in SARS-CoV-Infected Mice. Cell 2016;19:181-93. Chen J, Yang YF, Yang Y, et al. AXL promotes Zika virus infection in astrocytes by antagonizing type I interferon signalling. Nat Microbiol 2018;3(3):302-9. Dong N, Yang X, Ye L, Chen K, Chan EW, Chen S. Genomic and protein structure modelling analysis depicts the origin and pathogenicity of 2019-nCoV, a new coronavirus which caused a pneumonia outbreak in Wuhan, China [version 2; peer review: 1 not approved]. F1000Research 2020, 9:121 (https://doi.org/10.12688/f1000research.22357.2) Dowall SD, Bewley K, Watson RJ, et al. Antiviral Screening of Multiple Compounds against Ebola Virus. Viruses 2016;8(11). pii:E277. Hastings AK, Hastings K, Uraki R, et al. Loss of the TAM Receptor Axl Ameliorates Severe Zika Virus Pathogenesis and Reduces Apoptosis in Microglia. iScience 2019;13:339-50. Huang MT, Liu WL, Lu CW, et al. Feedback regulation of IFN-αβ signalling by Axl receptor tyrosine kinase modulates HBV immunity. Eur. J. Immunol. 2015;45:1696-705. Krebs M et al. A phase II study of bemcentinib (BGB324), a first-in- class selective AXL inhibitor, in combination with pembrolizumab in patients with advanced NSCLC: Updated analysis. SITC 2019, oral presentation in High Impact Clinical Trials session. Lemke G. How macrophages deal with death. Nat Rev Immunol. 2019;19(9):539-49. Loges S et al. Comprehensive Analysis of the Dose Escalation, Expansion and Correlates in the Ph I/II Trial BGBC003 with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in Relapsed/Refractory AML and MDS ASH 2018, presentation. Lokugamage KG, Hage A, Schindewolf C, Rajsbaum R, Menachery VD. SARS-CoV-2 is sensitive to type I interferon pretreatment. bioRxiv preprint doi: https://doi.org/10.1101/2020.03.07.982264.Meertens L, Carnec X, Lecoin MP, et al. The TIM Final, 22 April 2020 24 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) and TAM Families of Phosphatidylserine Receptors Mediate Dengue Virus Entry. Cell Host Microbe 2012;12(4):544-57. Meertens L, Labeau A, Dejarnac O, et al. Axl mediates ZIKA virus entry in human glial cells and modulates innate immune responses. Cell Rep 2017;18(2):324-33. Mercer J, Helenius A. Vaccinia virus uses macropinocytosis and apoptotic mimicry to enter host cells. Science 2008;320(5875):531-5. Shibata T, Habiel DM, Coelho AL, Kunkel SL, Lukacs NW, Hogaboam CM. Axl Receptor Blockade Ameliorates Pulmonary Pathology Resulting from Primary Viral Infection and Viral Exacerbation of Asthma. J Immunol. 2014;192(8):3569-81. Shimojima M, Takada A, Ebihara H, et al. Tyro3 family-mediated cell entry of Ebola and Marburg viruses. J Virol. 2006;80(20):10109-16. Strange DP, Jiyarom B, Pourhabibi Zarandi N, et al. Axl promotes Zika virus entry and modulates the antiviral state of human Sertoli cells. mBio 2019;10(4):e01372-19. Final, 22 April 2020 25 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) 7.0 APPENDICES Appendix 1 Abbreviations Abbreviation ACE AE AML BP CYP EBOV ECG GAS6 IC50 IC90 IFN IL MHV NK NYHA PD PD-1 PK PS QTcF RP2D RSV SARS SARS-CoV-2 SoA SOCS TAM TdP Definition Angiotensin-converting enzyme Adverse event Acute myeloid leukaemia Blood pressure Cytochrome P450 Ebola virus Electrocardiogram Growth arrest-specific 6 Half maximal inhibitory concentration Concentration required for 90% of maximum inhibition Interferon Interleukin Mouse hepatitis virus Natural killer New York Heart Association Pharmacodynamic Programmed cell death-1 Pharmacokinetic Phosphatidylserine QTc interval according to Fridericia correction Recommended Phase 2 dose Respiratory syncytial virus Severe acute respiratory syndrome Severe acute respiratory syndrome coronavirus 2 Schedule of Activities Suppressor of cytokine signalling Tyro3, AXL, MerTK Torsade de Points Final, 22 April 2020 26 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 2 Prohibited Concomitant Medication Due to QT Prolongation Risk or CYP3A4 Interaction with Narrow Therapeutic Index For any concomitant medication, please check the following website for the drug’s Torsades de Pointes (TdP) risk: https://crediblemeds.org/oncosupport/. Drugs with known (TdP) risk are reason for EXCLUSION. For drugs with a conditional risk, please review the product label and correct any abnormalities, eg, hypokalaemia. Common medication Associated with a Risk of QT Prolongation and TdP – USE PROHIBITED AS CONCOMITANT MEDICATION t½ less than 6 hours Azithromycin 2-4 hours$ Clarithromycin 3-4 hours$ Cocaine 0.6 – 1.3 hours$ Droperidol 2 hours$ Erythromycin 2 hours$ Ondansetron 3 hours$ Procainamide 2.5-4.75 hours$ Terfenadine 3.5 hours** t½ between 6 – 12 hours Cisapride 10 hours ** Disopyramide 6.7 hours$ Ketoconazole 3 – 10 hours$ Moxifloxacin 12 hours$ Quinidine 6 hours **$ Voriconazole 6 hours$ t½ greater than 12 hours Amiodarone 50 days$ Astemizole 24 hours ** Chloroquine 1-2 months$ Citalopram 35 hours$ Escitalopram 30 hours$ Fluconazole 30 hours$ Haloperidol 15 – 27 hours$ Methadone 25 – 55 hours$ Petamidine 10 – 14 days$ **also CYP3A4 substrates $ also TdP risk Pimozide 55 hours ** Sotalol 10 – 20 hours$ Thioridazine 21 – 24 hours$ Sensitive CYP3A4 Substrates With A Narrow Therapeutic Margin THESE MEDICATIONS SHOULD BE DISCONTINUED BEFORE ENROLMENT t½ less than 6 hours t½ between 6 – 12 hours t½ greater than 12 hours alfentanyl 90-111 minutes dihydroergotamine & ergotamine 2 hours Fluticasone 3 – 8hours Terfenadine 3.5 hours astemizole 7 – 9 hours cisapride 12 hours cyclosporine 8.4 hours Fentanyl 8 – 10 hours quinidine 6 hours tacrolimus (FK506) 12 hours pimozide 55 hours sirolimus 63 hours Woosley RL, Heise CW , Gallo T, Tate J, Woosley D and Romero KA, www.CredibleMeds.org, QTdrugs List, [14Apr2020], AZCERT, Inc. 1822 Innovation Park Dr., Oro Valley, AZ 85755 Final, 22 April 2020 27 CONFIDENTIAL ACCORD-2-002 - Sub protocol for Bemcentinib (Amendment 01) Appendix 3 Signature of Investigator PROTOCOL TITLE: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID-19 in Hospitalised Patients SUB-PROTOCOL NO: ACCORD-2-002 SUB-PROTOCOL FOR CANDIDATE AGENT BEMCENTINIB VERSION: Amendment 01 This sub-protocol is a confidential communication of the Sponsor. I confirm that I have read this sub-protocol, I understand it, and I will work according to this sub-protocol, in conjunction with the Master Protocol for the overall platform study. I will also work consistently with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and the applicable laws and regulations. Acceptance of this document constitutes my agreement that no unpublished information contained herein will be published or disclosed without prior written approval from the Sponsor. Instructions to the Investigator: Please SIGN and DATE this signature page. PRINT your name, title, and the name of the study centre in which the study will be conducted. Return the signed copy to the Contract Research Organization/Sponsor. I have read this sub-protocol in its entirety and agree to conduct this part of the study accordingly: Signature of Investigator: Printed Name: Investigator Title: __________________________ ___________________________ ___________________________ Date: ________ Name/Address of Centre: ___________________________ ___________________________ ___________________________ Final, 22 April 2020 28
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